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ON SETTING UP OF
IN MALAYSIAPRIVATE HOSPITALS
REQUIREMENTS AND PROCEDURES UNDER ACT 586
H A N D B O O K
MINISTRY OF HEALTH MALAYSIA
Private Medical Practice Control Section (CKAPS),Medical Practice Division
July 2019
Handbook on Setting up of Private Hospital in Malaysia
www.medicalprac.moh.gov.myI
© Malaysia Productivity Corporation 2019
ON SETTING UP OF
IN MALAYSIAPRIVATE HOSPITALS
REQUIREMENTS AND PROCEDURES UNDER ACT 586
H A N D B O O K
Prepared By:
Private Medical Practice Control SectionMedical Practice Division
Ministry of Health MalaysiaLevel 3, Block E1, Parcel E
Federal Government Administration Centre62590 Putrajaya
Tel : 03-8883 1307
In Collaboration With:
Malaysia Productivity CorporationLorong Produktiviti
Jalan Sultan 46200 Petaling JayaSelangor Darul Ehsan
Tel : 03-7955 7266
ALL RIGHTS RESERVED
Ministry of Health Malaysia
All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case of brief quotations embodied in critical reviews and certain other
noncommercial uses permitted by copyright law.
PRODUCTIVITY AND REGULATION
Productivity is the only driver of income growth that is unlimited, as opposed to resource exploitation or increase in population and labour force participation, each of which faces natural limits. The potential for productivity growth to generate higher income for Malaysians makes it a natural and important consideration for decision makers. As such the continuing need to stimulate productivity rightly remains at the forefront of government policies. Regulation is the lifeblood of a modern, well-functioning economy.
Almost all regulations have the potential to impact on productivity, either through the incentives which they provide to businesses to change operating and investment decisions, or more directly through their impacts on compliance costs. It is inconceivable to think of a modern economy functioning without regulation. However, poor regulation can cause frustration and unintended consequences, or simply add red tape that adds nothing useful to the economy, society or the environment.
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Private healthcare is an important component of Malaysia’s healthcare system and has constantly received intense policy attention. The Private Healthcare Facilities and Services Act 1998 [Act 586] and its regulations is a formulation of public policy toward private healthcare providers and their services.
The Private Medical Practice Control Section (CKAPS), Medical Practice Division is the regulator responsible to purview, control, regulate and monitor that the private healthcare operators comply with the relevant requirements under the act. At Ministry of Health (MOH), we acknowledge that an e�ective regulatory system contributes toward high growth and creates both economic and social benefits for all. We also recognise that regulation is a dynamic process and must be scrutinized, challenged and improved to ensure it takes account of our changing environment. This handbook is drafted with its main objective to facilitate the submitting persons to complete and comply with the requirements under the Act and thus, achieve the goal to reduce the number of days in obtaining planning approval.
This handbook is intended to provide a clear guide on the needs to comply with Act 586 (on the technical requirements) and help private hospital operators to submit a quality submission for a new private hospital development. A quality submission should have very minimal or no correction at all and this shall translate into less rework and resubmission – which means less time spent on the submission. I understand that numerous workshops and public consultations were organized by the
Focus Group on Dealing with Construction Permits (FGDCP) on Private Hospitals and progress reported to PEMUDAH. The Focus Group has also built in a capacity building, where MPC and CKAPS jointly organized a series of workshops and trainings were conducted directly by CKAPS to the technical and submitting persons (applicants) on how to submit a plan that satisfies the requirements of Act 586. I trust that this handbook will be followed through and advance further as a ground for continuous improvement in future.
I would like to congratulate and commend everyone who has contributed in accomplishing this handbook.
FROMFOREWORD
MINISTER OF HEALTH MALAYSIA
YB DATO' SERI DR HJ DZULKEFLY AHMAD
Handbook on Setting up of Private Hospital in Malaysia
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It gives me great pleasure to share with you this Handbook on Setting up of Private Hospitals in Malaysia. The first edition of this handbook will provide clarity on the requirements, processes and procedures for the licensing of private hospitals under the jurisdiction of the Ministry of Health.
Understanding Legislative requirements for hospital planning, design and construction process is critical when dealing with issues and activities associated with health and safety of the people is under the responsibility of the owner's supervisor.
Healthcare facilities and services licensing is essential to ensure the minimum acceptable standards are complied with, accountability of private healthcare provider towards patient’s safety is transparent, patient’s rights are upheld and quality assurance and processes are clearly defined.
This new handbook details the legislative framework which governs the operation of private hospitals. Clear description are provided to assist the processes and requirements for pre-establishment approval, approval to establish or maintain and license to operate or provide for private healthcare facilities and services.
I would like to express my appreciation to PEMUDAH members and Malaysia Productivity Corporation (as the secretariat of PEMUDAH) for their kind support and collaboration which has made this publication a success. My acknowledgement to all parties from the Ministry of Health who have directly or indirectly contributed their resources and experiences to
enrich the contents of the Handbook. We hope that this Handbook will serve as an important reference source for the ongoing improvement of the healthcare and professional standards in the non-Government sector in Malaysia.
FROMFOREWORD
CHIEF SECRETARY TOTHE GOVERNMENT OF MALAYSIA
DATUK SERI DR. ISMAIL HJ BAKAR
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I would like to congratulate Private Medical Practice Control Section, (CKAPS), Ministry of Health on the successful publication of this Handbook and delighted that PEMUDAH and Malaysia Productivity Corporation (MPC) is part of the collaborative e�ort. This is in line with our innovative collaboration with stakeholders in facilitating ease of doing business. PEMUDAH and MPC undertake regulatory review mandate by working closely with other government ministries and agencies to set out principles and guidelines on the conduct of regulatory reviews and design of new regulations, with a view that the new and revised regulations will reduce unnecessary regulatory burden (RURB) on business and contribute to the private sector’s competitiveness.
MPC has embarked on review of existing business regulations with the focus on the Productivity Nexus of the 9 priority subsectors and Healthcare being one of them. Among the completed RURB projects include ‘Reducing Unnecessary Regulatory Burdens in Business: Private Healthcare’ which sought commitment from the public and private sectors to remove unnecessary compliance costs and administrative burden while enhancing regulatory consistency in the private healthcare sector. The focus is on the private hospital sector as it is a high value added, high knowledge-based and growing sector of importance.
Although it is emphasized that compliance with these guidelines forms only one element of the private hospital licensing process, the comprehensive guidelines in this Handbook demonstrate the intent of the standard,
requirements, processes and procedures from the perspective of the Ministry of Health. It is critical as setting up a private hospital involves tremendous planning, finance, resources, approvals, certifications and guidelines. Thus if there are no clear guidelines it can lead to longer waiting time and this would a�ect the hospital planning e�ciency. Process uncertainty and unreliability would give rise to unnecessary burdens and high compliance costs. This Handbook is indeed timely in view of the increasing emphasis and demand for quality healthcare and services. Clear guidelines would greatly facilitate the establishment and maintenance of private hospitals and a variety of related healthcare facilities and services for both new and existing facility and operational processes.
I believe that this publication will have the widest possible circulation and be a useful reference for all those who are involved in providing healthcare.
FOREWORDFROMPEMUDAH CO-CHAIR
YBHG DATO’ DR. IR. ANDY K H SEO
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To achieve an inclusive and profound level of technical understanding, it is highly encouraged for this handbook to be read in tandem with the Handbook on Setting Up of Private Hospitals in Malaysia: Submission Process and Harmonisation of Technical Requirements which addresses fundamental requirements from various technical agencies involved in setting up a new private hospital. The list of harmonized requirements, procedures and/or guidelines are outlined in that handbook as reference and information for all stakeholders in both public and private sector.
By applying references to both handbook- users will be guided in a methodological way of application and submission processes whilst acquiring best practice of clinical, operational and framework of setting-up exemplary new private hospitals described in this handbook.
Both handbooks correlate and anticipated to serve as a guidance to facilitate businesses in their e�orts to comply with the technical requirements for setting up a new private hospital.
Option 3
Private Medical Practice Control Section (CKAPS), Medical Practice Division
July 2019
MINISTRY OF HEALTH MALAYSIA
ON SETTING UP OF
IN MALAYSIAPRIVATE HOSPITALS
H A N D B O O K
Submission Process & Harmonisationof Technical Requirements
Handbook on Setting up of Private Hospital in Malaysia
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C O N T E N T S
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47
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22
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CHAPTER 1: OVERVIEW
1.0 Introduction1.1 Private Healthcare Facilities and Services Act 19981.2 Other Laws Pertaining to Establishment and Operation of a Private Hospital1.3 Approval and Licensing Procedures Under Act 5861.4 Who Can Apply?
CHAPTER 2: APPLICATION FOR PRE-ESTABLISHMENT APPROVAL
2.0 Introduction2.1 How to Apply?2.2 Factors Considered in Pre-Establishment Approval
CHAPTER 3: APPLICATION FOR APPROVAL TO ESTABLISH
3.0 Introduction3.1 How to Apply?3.2 Factors Considered in Approval Application 3.2.1 Legal and Basic Considerations Providers’ Concept and
Intention 3.2.2 What is a Hospital? 3.2.3 Responsibilities of Person-In-Charge 3.2.4 Separate Approval & Licence3.3 Floor Plans 3.3.1 General Provisions 3.3.2 Wards 3.3.3 Specific Provisions According to Facilities
CHAPTER 4: APPLICATION FOR LICENCE TO OPERATE
4.0 Introduction4.1 How to Apply?4.2 Factors to be Considered
CHAPTER 5: QUESTIONS AND ANSWERS
5.0 Questions and Answers
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CHAPTER 1OVERVIEW
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Before establishing a private hospital, various factors have to be considered and carefully planned as healthcare industry is unlike others, whereby it involves human lives and impacts significantly on socioeconomic status on a community or a country. Among those factors are
It is imperative that the provider is clear on the intention of setting up a private healthcare facility or service (PHFS); what type of PHFS, what services that they will be o�ering and who are the professionals o�ering those services. For that matter, healthcare industry is a highly regulated industry as a the main aim is to protect the public from harm or from the adverse implications of business activities within healthcare system . Among the statutes that are aimed to safeguard the patients’ safety are as follows:
In 1948, the World Health Organization (WHO) defined health with a phrase that is still used today
“Health is a state of complete physical mental and social
well-being and not merely the absence of disease
or infirmity.”
START WITHA THOUGHT
HEALTHCARE:ACCESSIBILITY,EQUALITYSAFETYANDQUALITY
Resources
Legal Requirement& Authorities
Non-stop operation
1
2
3
1.0 Introduction
What Are Needed Before Establishment?
Intention Land andAsset
Money andInvestment
All relevantProfessionals
andHealthcare
Professionals
LegalRequirements
andAuthorities
PrivateHospital
WaterServicesIndustry
Act 2006
ElectricitySupply
Act 1990
Information& Technology
Security
FireServicesAct 1988
Equipmentand
Technology
Factories &MachineryAct 1967
HCP Acts &Employment
Act 2011
EnvironmentalQuality
Act 1974
OthersRelevant
Laws
Land-LocalAuthority
AllopathicMedicineEvidenceBasedMedicine
=
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Although there are various statutes governing the establishment of a private healthcare facilities, the approvals to establish/maintain and licences to operate/provide are issued under the Private Healthcare Facilities and Services Act 1998 [Act 586] and its Regulations. This Act was gazetted in 1998 and enforced in 2006 whereby the Ministry of Health (MOH) is the guardian and implementor of this Act. This book will address the approval and licensing processes under MOH.
This Act’s main objectives are as below:
The basic principle of Act 586 is to ensure that the three essential components (healthcare facilities, services and personnels) in healthcare facilities and services commensurate with each other.
1.1 Private Healthcare Facilities and Services Act 1998
Subsidiary Legislations Under Private Healthcare Facilities& Services Act 1998 [Act 586]
Private Healthcare Facilities & Services (Private Medical Clinics or Private Dental Clinics) Regulations, 2006 [P.U. (A) 137/2006]- 14 Parts with 109 Regulations & 7 schedules (1 May 2006)
Private Healthcare Facilities & Services (Private Hospitals and other Private Healthcare Facilities) Regulations, 2006 [P.U. (A) 138/2006]- 29 Parts with 434 Regulations & 13 schedules (1 May 2006)
Private Healthcare Facilities & Services (O�cial Identification Card) Order, 2006 [P.U. (A) 139/2006] (1 May 2006)
Private Healthcare Facilities & Services (Private Hospitals and other Private Healthcare Facilities) (Amendment) Order, 2013 [P.U. (A) 358/2013] (17 December 2013) & 2016 [P.U. (A) 260/2016] (15 Oktober 2016)
1.
2.
3.
4.
Private Healthcare Facilities & Services (Compoundable O�ences) Regulations, 2011 [P.U. (A) 170/2011] (1 August 2011) REPLACED BY Private Healthcare Facilities & Services (Compoundable O�ences) Regulations, 2017 [P.U. (A) 227/2017] (1 August 2017)
5.
Objectives of Act 586
Main Focus: To Safeguard Patients’Interest & Ensure Patients Receive Safe Treatment
Impose and ensure minimumstandards in the privatehealthcare facilities andservices.
Ensure integrity amonghealthcare
Ensure quality of healthcarefacilities and services e.g.Quality Assurance, MortalityReview etc.
Ensure professionalismamong all healthcareprofessions.
Address social andnational interest.
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The Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006 [P.U. (A) 138/2006] provides for the licensing of private hospitals and other private healthcare facilities to ensure that the minimum acceptable standards are complied with the provisions of the legislation, together with the mandated accountability of private healthcare providers towards patient safety, the upholding of patient rights, and the assurance of quality care. The provisions under the Act 586 stipulated the mandatory approval and licensing of all private hospitals and other private healthcare facilities and services for the protection of patients and the accessibility of healthcare consumers in the country.
Other than MOH, the hospital need to have approval from various regulatory bodies governing other aspects in the running of a hospital, such as below:
HealthcareFacilities
(Includingequipments)
HealthcareServices
HealthcarePersonnel
- all healthcare &healthcare related
professional &technical etc.
COMMENSURATES
1.2 Other Laws Pertaining to Establishment and Operation of aPrivate Hospital
Approvals needed for the HEALTHCARE FACILITIES & SERVICES from di�erent agencies
ACT REGULATEPrivate Healthcare Facilities & Services Act 1998
(Act 586) - MOH Healthcare Facilities & Services & its related matters.
The Atomic Energy Licensing Ct 1984(Act 304) - MOHRadioactive material, nuclear material / prescribed
substance
Factories and Machinery Act, 1967 (64/1967) By Department of Occupational Safety and Health
Steam boiler, Unfired Pressure Vessel + machinery equipment e.g. Autoclave, lift
Uniform Building By-Laws 1984 By Local Authorities Land, Certificate of Completion and Compliance of buildings or equivalent & signboard approval
Fire Services Act 1988 (Act 241) By Fire Department Safety for fire exit
Environmental Quality Act 1974 (Act 127) ByDepartment of Environment
Environment safety and clinical waste management
Workers’ Minimum Standards of Housing and Amenities Act 1990 (Act 446) - Human Resource Ministry Healthcare Facilities For estate workers
Medical Device Act 2012 (Act 737) - MDA Medical Device
Pathology Laboratory Act 2007 (Act 674) - MOH Pathology Laboratory (yet to be enforced)
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Registration and standard of training of healthcare professionals are governed by professional bodies, made up of 10 Boards and Councils. Professionals employed need to be registered and have their Annual Practicing Certificates renewed, while the medical practices are regulated by other statutes containing provisions related to medical and healthcare.
It is important that person who is establishing or operating a private hospital understands the licensing procedure under Act 586 to ensure that the operation of the hospital is not jeopardized in any way. The licensing procedures related to private hospitals are as below :
BEFORE OPERATION1. No objection on location (Pre-establishment Approval) –Section 9, Act 5862. Approval to establish (Form 1) – Section 8 – 13, Act 5863. Licence to operate (Form 3) = New Licence – Section 14-23, Act 586
Laws Governing Healthcare Professionals and Para Professionals
Allied Health ProfessionalAct 2016 [Act 774]
Allied HealthProfessionals
Traditional & ComplementaryMedicine Act 2016 [Act 775] TCM Practitioner
Estate hospital Assistants(Registration) Act 1965
(Revised 1990) [Act 435]
Estate HospitalAssistant
Midwives Act 1966 (Revised1990) [Act 436] Midwives
Nurses Act 1950 [Act 180] Nurses
Medical Assistants(Registration) Act 1977 [Act 180]
MedicalAssistants
Act 586 Technical Sta�/ Personal Care Aides etc
Registration of PharmacistsAct 1951 [Act 50],
(Revised 1989)[Act 371]Pharmacists
Optical Act 1991 [Act 469] Optician &Optometrist
Medical Act 1971 [Act 50] Medical Doctors
DentistsDental Act 1971 [Act 51]
Drugs & MedicinesPoisons Act 1952 (Revised 1989)[Act366]
Dangerous Drugs Act 1952 (Revised 1980)[Act 234]
Sale of Drugs Act (Revised 1989)[Act 368]
Therapeutic, Medical Education & ResearchHuman Tissues Act 1974 [Act 136]
Health Promotion Programmes and ActivitiesMalaysian Health Promotion Board
Act 2006 [Act 651]
AdvertisementsMedicines (Advertisement and Sale) Act 1956
(Revised 1983)[Act 290]
Infectious Diseases ControlDestruction of Disease-Bearing Insects Act 1975
[Act 342]
Regulation and Control PracticesTelemedicine
Telemedicine Act 1997 [Act 564]
Consent and Causing MiscarriagePenal Code [Act 574]
Health & Welfare of ChildrenChild Act 2001 [Act 611]
Fumigation of PremisesHydrogen Cyanide (Fumigation)
Act 1953 (Revised 1981)[Act 260]
Psychiatric ServicesMental Health Act 2001 [Act 615]
Food SafetyFood Act 1983 [Act 281]
Example of Laws Related to Healthcare Practices
1.3 Approval and Licensing Procedures Under Act 586
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DURING OPERATION1. Extension or alteration licensed Healthcare facility (Form 5) – Section 40, Act 5862. Renewal of Licence (Form 3) – Section 22 (Section 16-19) (Lampiran A, B, C)3. Amendment of an Approval and/or Licence (In writing) – Section 24, Act 5864. Transfer of an Approval and/or Licence (Form 8) – Section 53, Act 5865. Duplication of an Approval or Licence (In writing) – regulation 9 (section 107, Act 586)
TO END THE ESTABLISHMENT/OPERATION1. Disposal of an Approval or licence (Form 9) – Section 53, Act 586
The regulatory framework under Act 586 stipulates the procedure for establishing a private hospital, starting with the intention to provide or providing private healthcare facilities or services up until the closure of the hospital, particularly for continuing services such as haemodialysis treatment, critical care services and others.
Form 1Form 3
Form 5Amendment @ Form 8
Form 9
Form 2Form 4
Form 6Form 10/7
Letter
APPLICANT MINISTRY OF HEALTH
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Approval (COA) and Licence for private hospital may only be issued to a :1. Sole proprietor - RMP2. Partnership - partner ≥ 1 RMP3. Body corporate (Companies Act 2016) BOD ≥ 1 RMP
*RMP = “Registered medical practitioner” means any person who is registered as such under the Medical Act 1971 and who holds a valid practising certificate
1.4 Who Can Apply?
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CHAPTER 2APPLICATION FORPRE-ESTABLISHMENTAPPROVAL
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Pre-establishment approval application to Director General of Health, MOH is the first preliminary stage in the application to establish a private hospital, as stipulated under Section 9, Act 586.
2.0 Introduction
The application for pre-establishment approval is in writing and includes the following information :
2.1 How to Apply?
Application entity, as stated under Section 6, Act 586
Extensive renovation
Justification for the establishment of the private hospital in the area
Estimate of establishment costs
Exact location of the proposed hospital - full address of the proposed site and the map
Details of facilities - number of beds, number of operation rooms, equipment such as mammogram,MRI, CT Scan and other related equipment
Type of services that would be provided - whether multidisciplinary (surgery, obstetric) or niche
If there is any special equipment or services (such as haemodialysis or oncology), the name of the specialist(for example the nephrologist and clinical oncologist & nuclear medicine specialists) have to be stated
Other relevant matters for example to replace existing private hospitals or for the purpose of medicaltourism, provided that the applicant can justify the reason
Proposed manpower (relevant healthcare professionals and para professionals) : number of specialistsand sub-specialists, number of trained nurses, post basic trained nurses, allied health professionals etc,commensurating with the proposed healthcare facilities and services.
A feasibility study containing among others, a list of all public and private healthcare facilities with thenumber of beds within the radius of 30 km for Peninsular Malaysia and 50 km for Sabah and Sarawak inthe proposed location
Type of building - recommended building is “purpose built” with 5 dedicated entrances. If the buildinghas more than 12 clinical floors, applicant need to submit Hospital Disaster Management Plan (HDMP) whichis comprehensive, practical and reasonable. Multipurpose development must ensure that the facilities forthe hospital for instance lifts, stairs and 5 dedicated entrances etc are separated and not shared withnon-clinical facilities
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The following matters are considered (section 9 under Act 586):
MOH will liase with local councils, before issuing letter of no objection signed by the DG of Health, once the application is approved by the Evaluation Committee. the approval is non-transferable and is valid for 12 months. The period of 12 months is intended so that the applicant have su�cient time to submit formal Form 1 Application, as well as to provide the opportunity for other applicants who are interested and capable to provide healthcare services at that particular area, should the applicant is unable to build the hospital.
2.2 Factors Considered in Pre-establishment Approval
Garispanduan Permohonan Pra-Penubuhan bagi Hospital Swasta (Guidelines on Application of Pre-Establishment Approval for Private Hospital) available at the website of Medical Practice Division (www.medicalprac.moh.gov.my).
1 2
3 4
the nature of the healthcare facility or
service to be provided;
the extent to which the healthcare facilities or services are already
available in an area;
the need for the healthcare facility or
service in an area;
the futureneed for the health-
care facility or service in an area; or any
other matter which the Director General
of MOH thinks is relevant
• Apply on time (new licence and renewal of licence)• Complete application• Comply with requirements• Provide safe and quality healthcare services in accordance to relevant laws and policies• Ensure integrity and professionalism of all healthcare professionals• Implement quality improvement activities.
• Applicant• Site (location and site plan)• Healthcare facilities & equipments (includes architectural, mechanical and electrical
floor plans)• Healthcare services (general, specialised or sub specialised)• Healthcare professional and para professional (Qualified, trained, experienced & skilled)• Financial statement and arrangement
• a sole proprietor who is a registered medical practitioner (under Medical Act 1971);• a partnership which consists of at least one partner who is a registered medical
practitioner; or• a body corporate (registered under Companies Act 2016) whose board of directors
consists of at least one person who is a registered medical practitioner
• Getting No objection letter from Ministry of Health for the location (in writing);• Apply a Certificate of Approval to establish (Form 1); and• Apply licence (new) to operate and renewal every 2 years (Form 3)
Private Hospital
Requiredinformation
How toestablish
How to avoiddi�culties
Who canestablish/provide
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CHAPTER 3APPLICATION FORAPPROVAL TO ESTABLISH
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After receiving pre-establishment approval, the next step is to apply for approval to establish or maintain a Private Hospital. The applicant must complete Form 1 within 12 months from the date of the letter of pre-establishment approval. The pre-establishment approval is invalid past its expiry date, unless the applicant applies for extension.
3.0 Introduction
The application form can be downloaded from the website of Medical Practice Division (www.medicalprac.moh.gov.my) or obtained from Private Medical Control Section (CKAPS) either in Putrajaya or State Health State O�ce. Please refer to Prosedur Permohonan-permohonan Berkaitan Perakuan Kelulusan dan Lesen bagi Hospital Swasta (Procedures of Applications for Certificate of Approval and Licence for Private Hospitals), available at the website as well.
The complete application form (Form 1 in 2 copies) and supporting documents must be submitted together to the Medical Practice Division with processing fee as prescribed below:
Letter of acknowledgement and receipt of the processing fee will be sent to the applicant after the application is received. The application will be processed and once approved, certificate of approval signed by the Director General of Health will be issued to the applicant (Form 2).
The provider must be clear on the concept and intention of the hospital : a) Type and scope of the PHFS b) Who are the users? Patients and families, healthcare professionals, supporting sta�s etc c) Specific need of di�erent kinds of healthcare facilities and services in relation to the provider’s intention.
The general requirements in the Acts illustrates these main aspects: (a) Five (5) main entrances
(i) Main – public, wheelchair; (ii) Accident & Emergency – Walk-in patients and Emergency cases ; (iii) Kitchen; (iv) Service; and (v) Body hold.
(b) Functional zoning; in-patient, ambulatory, out-patient,
3.1 How to Apply?
3.2 Factors Considered in Approval Application3.2.1 Legal and Basic Considerations Providers’ Concept and Intention
No. of beds
ProcessingFee (RM)
< 25
2,000
25 - 49
2,500
50 - 99
3,000
100 - 199
3,500
> 199
4,000
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(c) Flow & Sterility; OT
(d) Patient safety and privacy – e.g. Linked buildings/apartment/hotel - no shared stairs or lifts, Nursery (controlled access), wards with balconies/windows,
(e) Standard for Lift, stairs, ramps
The layout of private hospital is governed by regulations and technical requirements. It is also a�ected by many less defined needs and pressures including workforce shortages, reimbursements, unethical practice, patient safety, advances in technology, and patient satisfaction. Di�erent expectation from di�erent users. The provider is required to decide the initial intention (policies) and then need to comply with the requirements pertaining to facilities, services, personnel, and quality. The following are among the factors to be considered by the provider:
• Hospital buildings designed with elements to help decrease medical errors, lengths of stay, hospital acquired infections, harm to patients and sta.
• Hospital that enable multidisciplinary interaction, promote sta wellbeing and enhance the safe and e�cient delivery of patient care.
• An optimal design may include extensive diagnostics, a multimodality procedure centre, and short stay beds.
Accessibility2
Flexibility andexpandability3
Securityand safety4
Cleanliness andsanitation5
Sustainability8 Aesthetics7Therapeuticenvironment6
E�ciencyand costE�ectiveness
Consideration: Good Layout
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• Layout of clinical rooms that promote safety, good communication, and privacy
• Conducive to the daily practice of the clinician performing bedside examinations and procedures (doctors are taught to examine patients from the right side)
• Physician on-call rooms (appropriately located)
• Optimal sink design and location promotes hand washing (important element in infection control) especially within acute care areas
• Private patient rooms may lower the risk of hospital acquired infections, reduce stress from noise, accommodate families more comfortably, and reduce room transfer
• May incorporate innovative ideas into the design of hospital buildings, such as integrating gardens into clinics and intensive care units (with proper step to prevent contamination/infection)
• It is challenging to balance the user’s functional needs with the risks and benefits of capital costs and ongoing operating savings.
• Developing a narrow floor plate to allow more access to daylight may increase cost because of the additional building perimeter, glazing and materials it requires, but incorporating evidence based design features such as windows for natural light, additional sinks for infection control, and single patient rooms, can lead to cost savings by reducing medical errors, nosocomial infections, and patient transfers.
• Hospital designed with maximum adaptability and flexibility to accommodate change and provide room for future growth and changes in service delivery.
• Patient-centred care: Easy point to be accessed by any point of the area
• Design for patient and family wellbeing • Intensive care patient room with floor to ceiling glass and outside access to garden space • ICU waiting rooms design for the family comfort with humanizing factors • Paediatric – school
• Consistent design for patient rooms, clean utility areas, nursing stations
• Minor injury not exposed to the major trauma cases
• Diagnostic and trauma centre nearby
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“Private hospital” means any premises, other than a Government hospital or institution, used or intended to be used for the reception, lodging, treatment and care of persons who require medical treatment or su�er from any disease or who require dental treatment that requires hospitalisation (S.2, Act 586)
A hospital is known as multidiscipline hospital if it provides these 7 disciplines namely: Medical, Surgical, Obstetric & Gynaecology, Paediatric, Orthopaedic, Radiology and Anaesthesiology. A hospital is typically made up of in-patient services, ambulatory care services, specialist outpatient services and emergency services supported by clinical and non-clinical support services.
Each discipline may have specialties and subspecialties. Please refer to the National Specialist Registry website at www.nsr.org.my to get the latest listing of specialty and subspecialties.
3.2.2 What is a Hospital?
BASIC DISCIPLINES
• IN PATIENT• AMBULATORY CARE• SPECIALIST OUT PATIENT• EMERGENCY
• MEDICAL• SURGICAL• O&G• PAEDIATRIC• ORTHOPAEDIC• RADIOLOGY• ANAESTHESIOLOGY
SUPPORT SERVICES
• CLINICAL• NON-CLINICAL
What is a HOSPITAL?
Medical and Dental Specialties Example in a Private Hospital
ANAESTHESIOLOGY AND CRITICAL CARE
EMERGENCY MEDICINE
INTERNAL MEDICINE
INTENSIVE CARE (ANAESTHESIOLOGY)
CARDIOLOGY (Non-Invasive/Interventional)
CLINICAL HAEMATOLOGY
DERMATOLOGY
ENDOCRINOLOGY
GASTROENTEROLOGY & HEPATOLOGY
GERIATRIC MEDICINE
INFECTIOUS DISEASES
INTENSIVE CARE (MEDICINE)
NEPHROLOGY
NEUROLOGY
PALLIATIVE MEDICINE
RESPIRATORY MEDICINE
MEDICAL ONCOLOGY
RHEUMATOLOGY
SPECIALTIES SUBSPECIALTIES
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NUCLEAR MEDICINE
REHABILITATION MEDICINE
SPORTS MEDICINE
CLINICAL ONCOLOGY
RADIATION ONCOLOGY
CLINICAL RADIOLOGY
GENERAL PAEDIATRICS
GENERAL PATHOLOGY
ANATOMICAL PATHOLOGY
CHEMICAL PATHOLOGY /
WITH METABOLIC MEDICINE
HAEMATOLOGY
MEDICAL MICROBIOLOGY
FORENSIC PATHOLOGY
TRANSFUSION MEDICINE
CLINICAL GENETICS
ADOLESCENT MEDICINE
DEVELOPMENTAL PAEDIATRICS
NEONATOLOGY
PAEDIATRICS AND CHILD HEALTH
PAEDIATRIC CARDIOLOGY
PAEDIATRIC DERMATOLOGY
PAEDIATRIC ENDOCRINOLOGY
PAEDIATRIC GASTROENTEROLOGY
PAEDIATRIC HAEMATOLOGY & ONCOLOGY
PAEDIATRIC INFECTIOUS DISEASES
PAEDIATRIC INTENSIVE CARE
PAEDIATRIC NEPHROLOGY
PAEDIATRIC NEUROLOGY
PAEDIATRIC RESPIRATORY MEDICINE
PAEDIATRIC RHEUMATOLOGY
OBSTETRICS AND GYNAECOLOGY (O & G)
PSYCHIATRY
GENERAL SURGERY
CARDIOTHORACIC SURGERY
NEUROSURGERY
PAEDIATRIC SURGERY
MATERNAL FETAL MEDICINE
REPRODUCTIVE MEDICINE
GYNAE-ONCOLOGY
CHILD AND ADOLESCENT PSYCHIATRY
FORENSIC PSYCHIATRY
URO-GYNAECOLOGY
BREAST / AND ENDOCRINE SURGERY
COLORECTAL SURGERY
HEPATOBILIARY SURGERY
THORACIC SURGERY
UPPER GIT SURGERY
VASCULAR SURGERY
SPECIALTIES SUBSPECIALTIES
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SPECIALTIES SUBSPECIALTIES
PLASTIC SURGERY
DENTAL SPECIALTIES
ORTHODONTICS
ENDODONTICS
RESTORATIVE DENTISTRY
PERIODONTOLOGY
ORAL MAXILLOFACIAL SURGERY
PAEDIATRIC DENTISTRY
ORAL MAXILLOFACIAL IMAGING
SPECIAL CARE DENTISTRY
FORENSIC ODONTOLOGY
ORAL PATHOLOGY & ORAL MEDICINE
OPHTHALMOLOGY
OTORHINOLARYNGOLOGY
ORTHOPAEDIC SURGERY
UROLOGY
SPINE SURGERY
ARTHROPLASTY
UPPER LIMB AND MICROSURGERY
ARTHROSCOPY & SPORT SURGERY
PAEDIATRIC ORTHOPAEDICS
FOOT & ANKLE
ORTHOPAEDIC ONCOLOGY
MUSCOSKELETAL TRAUMA
(Specialties as listed at National Specialist Registry website, last accessed 1 July 2019)*
OPHTHAL
MOLOGY
CARDIOLOGY RADIOLOGY PEDIATRICS
OPHTHALMOLOGY TRAUMATOLOGY SURGERY
NEUROLOGY TRAUMATOLOGY HEMATOLOGY
FAMILY MEDICINE PSYCHIATRY OTORHINOLARYNGOLOGY
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INPATIENT SERVICES
MEDICAL
SURGICAL
0&G
PAEDIATRIC
NEONATAL
CRITICAL CARE OR INTENSIVE CARE
EMERGENCY SERVICES
REHABILITATION
ENDOSCOPIC
OTHERS, PLEASE SPECIFY
Refer to specialist registry
BASIC 7 SERVICES
MEDICAL
SURGICAL
0&G
PAEDIATRIC
ORTHOPAEDIC
RADIOLOGY
ANAESTHESIOLOGY
In Patient Services: Example
PATIENT CARE RELATED SERVICES
ANESTHESIA
RADIOLOGICAL OR IMAGING
NURSING
BLOOD BANK
HAEMODIALYSIS
LABORATORY
ALLIED HEALTHCARE
PRE-HOSPITAL
AMBULANCE
CENTRAL STERILISING MEDICAL-SURGICAL
DIETARY
HOME NURSING
PHARMACEUTICAL
OTHERS, PLEASE SPECIFY
CLINICAL HAEMATOLOGY
PAIN MANAGEMENT
PATHOLOGY
Patient Care Related Services: Example
Pathology and Laboratories
Examples of in-patient services are as follows:
Examples of patient care related services are as follows:
Pathology and Laboratories provides diagnostic and screening laboratory tests across a wide range of specialties, including:
• Haematology • Biochemistry • Immunology • Microbiology • Genetics • Cellular Pathology • Molecular Diagnostics
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Clinical Support Service
A term of art for any department that largely functions behind the scenes in patient management, providing diagnostic services (e.g. histopathology), imaging, therapeutic support (e.g. pharmacy), and acute services.
• Anaesthesia • Adult Critical Care • Clinical Haematology • Resuscitation • Pain Service • Pathology and Laboratories • Radiology and Imaging • Pharmacy
Radiology and Imaging
Radiology and Imaging provides diagnostic and therapeutic radiology across a wide range of modalities including:
• Plain film • CT • MRI • PET/ CT • Nuclear medicine • Ultrasound • Mammography • Interventional radiology • Angiography • Fluoroscopy
Ambulatory Care
“Private ambulatory care centre” means any premises, other than a Government ambulatory care centre, private medical clinic or private dental clinic, primarily used or intended to be used for the purpose of performing any procedure related to the practice of medicine in any of its disciplines or any dental procedure and with continuous relevant private healthcare services including nursing services whenever a patient is in the premises, and in which healthcare, beds or other accommodation for the stay of any one patient for a period of not more than 23 hours is provided and from which patients are either discharged in an ambulatory condition without requiring constant or continuous care or supervision and without danger to the continued well-being of the patient or transferred to a hospital
Admissions restriction
Reg 340, Act 586 states that all procedures and surgeries shall be limited to those that -
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Specialist Out Patient Services
As per Reg. 334, Act 586 a private hospital can only provides specialist outpatient facility and service.
Non-Clinical Support Services
Examples of these services are laundry, housekeeping (environmental services) and patient transport & logistics.
“Person in charge” means a person possessing such qualification, training and experience as may be prescribed and who shall be responsible for the management and control of the private healthcare facility or service to which a licence or registration relates.
The responsibilities are listed below:
• Section (31)(a), Act 586 : (1) (a) A licensee or a holder of certificate of registration in respect of a licensed or registered private healthcare facility or service shall ensure that the licensed or registered private healthcare facility or service is maintained or operated by a person in charge
Anaesthesiology
Emergency Medicine
Family Medicine
General Medicine
General Surgery
General Paediatrics
Obstetric & Gynaecology
Orthopaedic and Traumatology
Ophthalmology
Otorhinolaryngology (ENT)
Psychiatric
Oncology
Radiology
Nuclear Medicine
Oral Health
Medicine Rehabilitation
Aviation Medicine
Sports Medicine
Pathology
Allied Health Support Services
Other Service
3.2.3 Responsibilities of Person-In-Charge
(a) do not exceed twenty-three hours combined operating and recovery or convalescent time; and
(b) do not generally result in extensive blood loss, require major or prolonged invasion of body cavities, directly involve major blood vessels or constitute an emergency or life-threatening procedure.
Service o�ered at ambulatory care are as follows: • MEDICAL • SURGICAL • O&G • PAEDIATRIC • NEONATAL • REHABILITATION • ENDOSCOPIC • OTHERS, PLEASE SPECIFY
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• Section 32, Act 586 : (1) A person in charge of a licensed or registered private healthcare facility or service shall hold such qualification, have undergone such training and possess such experience as may be prescribed.
• (2) A person in charge shall carry out such duties and responsibilities as may be prescribed.
* prescribed ~ by the Minister by order or regulations made under this Act)
On the other hand, Section 31(2), Act 586 states that not withstanding paragraph (1)(a), di�erent persons may be appointed to manage and assume the duties and responsibilities relating to non-clinical matters including financial, administration and management of non-clinical resources
FOURTH SCHEDULE(Regulation 12)
QUALIFICATION, TRAINING AND EXPERIENCE OFPERSON IN CHARGEPRIVATE HOSPITAL
P.U.(A) 138/2006Reg.12. A person in charge of a licensed private healthcare facility or sevice shall hold such qualification, have undergone such training and possess such experience as stipulated in the Fourth Schedule
PIC Qualification Training Experience
RegisteredMedicalPractitioner
Degree in Medicine from local universities or from other universities recognised by the Government of Malaysia; and
Registered with the Malaysian Medical Council
At least 2 years training in any specialty provided by the healthcare facility or service
Has served in a post in public service or has been granted, reduction, exemption or postponement from period of service under Section 42 of the Medical Act 1971; and
At least 2 years experience in hospital management
In general, separate approval and licence have to be applied if the private healthcare facilities or services other than private medical clinic or private dental clinic are not physically, administratively or organizationally linked.
3.2.4 Separate Approval and Licence
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There are general provisions and specific provisions on floor plan as follows:
a) General Provisions
b) Specific Provisions according to Facilities
1. Location
2. Sign and Labels
3. Patient transport
4. Ramp
5. Entrance and Exit
6. Door
7. Area for stretcher
and wheelchairs
8. Stairway
9. Elevator
10. Corridor
11. Floor and Wall
12. Ceiling
13. Window and ventilation
14. Electrical supply
15. Plumbing
16. Hand washing facilities
17. Water supply
18. Refuse and hazardous waste
19. Sewage and sewerage system
20. Enough space for displayed
21. Nursing unit
22. Nurse station
23. Medical record system facilities
24. Medicine preparation room or area
25. Examination and treatment room
26. Resuscitation facilities
27. Blood storage facilities
28. Pantry
29. Clean utility room
30. Soiled utility room
31. Janitor’s closet
32. Housekeeping
33. Patient room/ward
34. Toilet facilities
35. Bathing facilities
36. Sta� facilities
37. Public Amenities
38. Mortuary or body-holding room
• Operation Theatre, Central Sterile Services Department (CSSD)• Intensive Care Unit, Coronary Care Unit & High Dependency Unit (ICU, CCU & HDU)• Special Care Nursery• Neonatal Intensive Care Unit (NICU)• Labour Room• Nursery• Blood Bank• Emergency and Radiology• Haemodialysis Unit• Clinic• Rehabilitation Unit• Pharmacy• Kitchen• Laundry
3.3 Floor Plans
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3.3.1 General Provisions
1 Intensive Care UnitPaediatric ICUCoronary Care UnitCSSD/TSSUEndoscopyDay CareCath LabOperating Theatres
Location: • Free from undue noise (no disturbance to patients and sta�) • Not exposed to excessive smoke, foul odours or dust • Avoid outpatient tra�c through inpatient areas • The ambulatory care centre shall be physically separated from other facility and service (functional zoning) • Construction prevents entrance and harbourage of rodents and insects.
Signs and Labels: • Proper signage and labelling system must be installed. • They must not mislead the public on the type or nature of facilities or services. • Adequate and easily visible signage will ensure ease of way finding the relevant department, unit or ward in the hospital.
The word “Wellness Centre” should not be used as it can be misleading to the public. It is a common term used for beauty spas, massage centres and others
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Patient Transport: • Arrangement for patient transport is important to ensure that the hospital is easily accessible by ambulances and other types of transports. • Patient shall be transported by properly equipped and sta�ed ambulance (refer requirements for ambulance) • Vehicle used to transport patients without pre-hospital or nursing care is exempted from ambulance requirements
Ramp: • Size ≥1.1m wide • Landing ≥1.8m wide • Non-skid surface • Handrails on both sides (where necessary) • Guardrails and other safety devices (where necessary) • Slope not exceeding 1:16 • Comply with the Fire Services Department
Guardrails
Handrails
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Entrance and Exit: • Main entrance adjacent to lobby with minimum disturbance • Entrance designed for wheelchairs and stretchers • Separate emergency entrance (accessible to pedestrian, ambulance and tra�c) • Separate service entrance (close to storage room/area, elevators and kitchen) • Separate patients and visitors entrance • Separate exit for deceased (no obstruction). These requirements are important for good tra�c flow in the hospital and so that entrance and exit are accessible to patients on wheelchair, and disabled patients.
AmbulanceDrop O�
Walk-inPatient
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Separate SERVICES entrance (subreg. 59(6))
Separate Exit For Deceased (Subreg. 59(6))
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Door: • Clear opening ≥1.2m (for patient care) • Clear opening patients’ toilet and bathroom door ≥0.9m, not swing in, neither to corridor • Adequate size for large carts or bulk goods to pass through (for entrance, store etc.) • All 2 way swing doors shall have vision panel • Clearance at the bottom of exterior door ≥0.6cm • All doors except closet doors shall not swing into the corridors • Adequate area for stretchers and wheelchairs to pass through
The reason why the door should not swing in is to enable healthcare professionals to open the door during emergency cases, without pushing the patient further into the toilet/ injuring the patient while opening the door.
At the same time, it should not swing into the corridors so that the passerby using the corridors will not be injured when the door is opened.
Doors should not swing into corridors
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Stairways: • Size ≥ 1.1m wide • Landing ≥ 1.8m wide • Non-skid surface • Handrails (both sides) • Guardrails (where necessary) • Comply with Fire Services Department • No carpet
TIP If there is constraint of space, the usage of sliding doors and folding doors for toilets is allowable provided it fold outside but not to corridors.
Measurement is from wall to handrail
Landing ≥ 1.8m
Width of stair ≥ 1.1m
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Example of compliance at risk when there is presence of column at the stairways which may jeopardize the size of the landing
Elevators (Lifts): • Clear opening ≥1.2m • Size ≥1.5m x 2.1m • Capacity ≥1,500 kg • DOSH certification (CF) (Display and comply with DOSH’s standards and requirements. • 1 elevators [if patient facilities (e.g. patient room, operating room, labour-delivery room, treatment room etc.) located on other than ground floor] • 2 elevators (if > 60 beds or its equivalent on other than ground floor) • 3 elevators (if > 200 beds or its equivalent on other than ground floor)
*Kept in good repair and operating condition
The reason why the elevators for patients need to comply to certain standards is during transportation of critically ill patients, healthcare personnels and multiple equipments are needed to accompany the patients.
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Example of compliance at risk when there is presence of column in the middle of corridors
Corridors: • Size ≥ 2.1m wide (exceptions may be permitted for corridor limited to foot tra�c in a single department) • Handrails on both sides (compulsory for patients with physical disabilities unit i.e orthopaedic & rehabilitation units) • No beds shall be placed in corridors
Measurement of corridor is taken from handrail to handrail.
Floor and Walls: • Easy to wash and clean & non skid for floor • Non-toxic (safe)
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Ceiling: • Height for air-conditioned room ≥2.4m. • Height for non air-conditioned room ≥3.0m. • Non-toxic (safe) material.
Windows and Ventilation: • Window in all patient rooms except labour room • All rooms and areas adequately ventilated • Adequate ventilation system to provide 10ACH without recirculation in rooms/areas with excessive heat, moisture, odours & contaminants originate • Microbiology work rooms or areas shall not have any recirculation of air and shall be air-conditioned • Fresh air supply intakes away from any source of contaminants or odours • Air discharge exhaust located to avoid cross circulation to air supply intakes or windows • Ventilation system to avoid contiminated air flow to patient, food preparation, clean or sterile areas • Air from rooms/areas likely to contain infectious microorganisms or noxious gas shall be exhausted and not recirculated through the normal air-conditioning system • The ventilation system shall be capable of removing toxic and noxious fumes and provide adequate fresh air to the laboratory • All air supplied to sensitive room or areas shall be delivered at or near the ceiling of such room (OT, LR, Nurseries)
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Electric Supply: • Appropriate and grounding type of electrical sockets • Adequate number of electrical sockets • Uninterrupted power supply for life support systems • No adaptors, extension cords or junction boxes • Adequate lighting fixtures for illumination in all areas • Circuit-breakers in all critical areas and located in or adjacent to the areas • Emergency power supply for the essential systems, equipment, rooms or areas (call system, alarm system, critical areas, etc.) • Emergency power supply for the illumination (exit signs, nurses’ station, corridor etc.) • On site fuel storage to sustain emergency electrical generating equipment operation for eight hours. • Emergency lights are kept in good repair and operating condition.
Plumbing: • Designed and installed, to be easily cleaned and maintained. • No floor traps in clean areas, OT and critical care units. • Installation to prevent the possibility of cross connection between safe and unsafe water supplies or back siphonage
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Hand Washing facility: • Soap, appliance and sanitary hand drying facilities. • All taps are patient-friendly (except for psychiatric patients). • Hands-free taps (for healthcare professional).
Plumbing: • Safe and su�cient water supply according to standards approved by relevant authority - Water tank with material approved by relevant authority and properly maintained. • A reliable supply of good quality water will enable the facilities to provide access to safe hygiene, sanitation and health care waste management and to control the spread of health care settings associated infections.
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Refuse and Hazardous Waste: • Kept in imprevious, non-absorbent with close and tight-fitting lids & easily washed containers • Su�cient number of sound watertight containers with tight fitting lid • Separate handling of infectious and non-infectious waste at the point of generation • Proper disposable of infectious waste in designated containers • Handling of non infectious waste in accordance with good safety practice and related law • Handling all hazardous waste in accordance to relevant authority to protect persons and environment
Sewage and Sewerage System: • No exposed sewer line be located directly above working, storing or eating surfaces or areas or where medical or surgical supplies are prepared, processed or stored
Display in a Conspicious Area: • A copy of Licence (for renewal of Licence) • Organizational chart • Duty roster • Policy statement on sta� identification • Policy statement on billing procedures • Policy statement on valid consent-requirement and manner • Policy statement on patient’s right for information on medical treatment and care and grievance procedure • Policy statement on patient’s right for medical report • Emergency call information (with contact number) • Information such as above are important to inform users about the unit/department/facility. Information sharing will also improve the unit’s management and service level and enhance its brand and core competitiveness. The information also allows real-time access by the users.
Nursing Unit: • Nursing unit for a separate physical and functional unit • Group of patients’ room or ward • Ancillary administrative facilities for nursing service • Ancillary service facilities (related to nursing service) • Located on the quiet side of the healthcare facility • Separated from service and ambulance areas • Avoid through tra�c to any service, diagnostic, treatment or administrative facilities • No through tra�c in infectious diseases and psychiatric units to any other area of the healthcare facility • All rooms and areas for each unit on the same floor level
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Nurse Station: • 1 station: 36 beds • Distance ≤24.4m from patients’ rooms. • Area for writing patients’ records and charts (at or nearby) • Clinical hand washing facilities (at or nearby) • With a nurse call system: communication system available within and with other facilities in electronic system • Call systems are kept in good repair and operating condition • Medication preparation room or area (at or nearby) • Toilet with hand washing facility for sta� (nearby)
Medicine Preparation Room or Area: • Locked cabinet for dangerous drug • Work space for preparation of medication • Sink with hand washing facilities • Refrigerator with thermometer and exclusively for pharmaceutical storage • No test reagents, general disinfectants, station cleaning agents and similar products in this room or area
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Examination and Treatment Room: • Doors clear opening ≥1.2m and must not swing into the corridors • Adequate ceiling height (air condition 2.4m, non-air conditioner 3.0m) • Dimension ≥3.0m • Area ≥11.1m • Hand washing facility • Examination light • Storage for linen, supplies and equipment • Examination and treatment couch • Screen or curtain for patient privacy • Located near nurses station or where patient care is provided or procedure is carried out • Contaminated equipment shall not be used for patients
TIP Medication preparation and dispensing areas must be adequate in a hospital
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Resuscitation Facilities: • Ventilation assistance equipment (e.g. ambubag, airways) • Laryngoscope and endotracheal tubes • ECG monitoring with cardiac defibrillator • Suction equipment • Oxygen • Urinary catheters • Drugs (Adrenaline, Atropine, Steroid, S. Bicarb) • Intravenous therapy • Basic obstetric supplies
Blood Transfusion Facilities and Services: • Private hospitals with regular emergency care services shall maintain a minimum blood supply in its premises at all times for its daily use or in a position to obtain blood quickly from other licensed or Government facilities • Blood and blood products shall be stored in refrigerators.
TIPEmergency trolleys are developed and placed in strategic locations to improve the e�ciency of the medical teams’ response to emergencies survival. The trolleys are routinely checked and if used, are restocked. This process is audited regularly. Make sure all sta� know the location of these trolleys. Proper legend must be shown in floor plan
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Nourishment Station or Pantry: • Sink with hand washing facilities • Serving equipment (between schedule meals) • Refrigerator • Storage cabinet • Source and preparation of ice used for patient service or treatment shall be clean and hygienic
Clean Utility Room: • At least one room per nursing unit • A counter and space for the storage • No hand washing sink • Air-conditioned room • Clean linen storage separate from laundry
Dirty Utility Room: • At least one room per nursing unit • Work counter • Waste receptacle • Soiled linen receptacle • Washing equipment • Clinical sink • Double compartment sinks to clean utensil and equipment with adequate counter space on both sides and depth (according to its function)
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Janitor’s Closet and Housekeeping: • Sink (preferably with a floor receptor with mixing taps) • Hook strip for mop handle • Shelf for cleaning material • Waste receptacle with impervious linear • Hand washing facility • Adequate space for mop, bucket and cleaning equipment • Housekeeping services properly operated and maintained to provide a pleasant, safe and sanitary environment • Availability and properly maintained equipment for cleaning • Cleaning compound and hazardous substance are labelled and stored in safe places • No dry dusting and sweeping • This room is important to deliver day-to-day cleaning services for a defined area. The space and area must able to adequately store for cleaning materials and equipment in daily use.
TIPSupport facilities such as clean utility room, dirty utility room and janitor's closet may be shared provided the areas -• have similar level of cleanliness• same level or clinical floor• distance from the said support facility ≤24.4 m
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3.3.2 Wards
The general requirements for ward are as below:
• Door, corridor, ceiling • Areas for stretchers & wheelchairs • Window and ventilation • Handwashing facilities • Refuse & hazard waste • Nursing station • Appropriate patients’ medical record system facilities • Medicine preparation room/area • Examination and treatment room • Resuscitation facilities • Nourishment station or pantry • Clean utility room • Dirty utility room • Janitor’s closet • Room/ward • Toilet facilities • Bathing Facilities
Location: • Free from undue noise (no disturbance to patients & sta�) • Not exposed to excessive smoke, foul odours or dust • Avoid outpatient tra�c through inpatient areas • The ambulatory care centre shall be physically separated from other facility and service • Construction prevents entrance and harbourage of rodents and insects
Door: • Clear opening ≥1.2 m (for patient care) • Clear opening patients' toilet and bathroom door ≥0.9m, not swing in, neither to corridor • Adequate size for large carts or bulk goods to pass through (for entrance, store etc.) • All 2 way swing doors shall have vision panel • Clearance at the bottom of exterior doors ≥0.6cm • All doors except closet doors shall not swing into the corridors
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Corridors: • Size ≥2.1m wide (exceptions may be permitted for corridor limited to foot tra�c in a single department) • Handrails on both sides (compulsory for patients with physical disabilities unit) i,e orthopaedic & rehabilitation units • No beds shall be placed in corridors
Areas for wheelchairs and stretchers
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Patient Room / Ward: • Separated for male and female (≥12 year old) • separated for paediatric (≤12 years old) • Doors clear opening ≥1.2 m & not swing onto the corridors • Adequate ceiling height (air condition ≥2.4 m, if not ≥3.0m) • Dimension for single bedded room ≥3.0 m • Area for single bedded room ≥10m • Clear space between sides / foot of bed from walls ≥0.9 m • For multiple bedded room : 1.5 m between beds • Separate locker for each patient • Bed head lamp/toilet lights/ night lights/ light switch adjacent to doors to patients' room • A nurse call system (within easy reach of each bed) • Cubicle curtains with built-in curtain tracks • Hand washing facilities • Patient with infectious and communicable disease shall not be admitted with non- infectious or non-communicable disease • No beds shall be placed in corridors or other than patient room areas except in case of emergency • Distance from nurses' stations ≤24.4m
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Toilet Facilities: • Clear opening for patients’ toilet door ≥0.9m and must not swing inward, neither into corridor • Ratio 1 toilet: 4 beds; adjacent or within patients’ room. • Disabled person-friendly (fit in wheel chairs) with: - Incombustible waste-paper receptacle with removable impervious liner - Grab bar - Nurse call system - Hand washing facilities • Toilet for healthcare professional in each patient care unit • Separate toilets for male and female sta� • No carpet
Bathing Facilities: • Ratio 1 shower: 4 beds • Grab bar • Nurse call system • Adequate space to fits in wheelchair • Clear opening for patient’s bathroom door 0.9m and must not swing inward, neither into corridor • No carpet • No laundry conducted here
Sta� Facilities: • Shall commensurate with the type, scope and capability of PHFS • Sta� rest or area • Sta� toilet - separate for male and female • Prayer room • Library or resource centre
Public Amenities: • Commensurate with the type, scope and capability • Separate toilets for male and female • Toilet for disable (where feasible) • Room or area for nappy change • Easily accessible public telephone within the facility • Cafeteria location does not hinder patient care activities (if available) • Breastfeeding room with nappy change facilities • Clean and separated prayer room and ablution area for male and female (optional)
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Mortuary or Body Holding: • Dedicated entrance to avoid transfer through public areas • Separate facilities for Muslim and non-Muslim bodies (Refrigerator) • Separated from other rooms or areas • Well-ventilated body-holding room • If autopsy is performed within the facility (optional), the autopsy facilities shall be provided with specified facilities and equipments.
Operating Theatre (OT):Requirements related to OT are as below:
• Location • Signs and labels • Proper internal room zoning (treatment and non treatment zones) and flow • Transfer area • Sta� facilities • Administrative facilities • Display area • Preparation area • Operation room
• Scrub area• Recovery area• Clean up room• Clean utility• Dirty utility• Janitor’s room• Substerilizing facilities• Sta� facilities
3.3.3 Specific Provisions According to Facilities
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Location:In terms of requirement pertaining to OT related to locations, these are the aspects that need to be looked into:
• Free from tra�c flow • Avoid direct tra�c between OT and LR • Limited access by an outpatient • Lift available for vertical transfer to OT , • Clear opening ≥ 1.2m, size ≥ 1.5m x 2.1m, capacity ≥ 1,500 kg • Ancillary facility outside OT • Direct connection to CSSU serving for OT only
Non-Treatment Zone: • Washing Room • Sterile Store • Sta� Room and Changing Room
The airlock is made up of two doors whereby the two cannot be opened simultaneously through electrical interlocking. It physically seals a surgical department from the rest of the environment. Airlocks may be used to control the entry of personnel into the OT to ensure dust or small particles entry are limited. Other than that, it helps to reduce temperature fluctuations when doors are opened.
Proper Internal Room Zoning(R.187, 193-Availability of proper internal room zoning:Treatment Zone: • Reception • Induction/Preparation Area • Operation Room • Recovery Area
Appropriate sta�, patient, equipment flow
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Transfer Area: • Able to fit 2 transfer trolleys/bed • Transfer line (red line) • Airlock
Administrative Facilities: • Control station with telephone and permit visual surveillance of all tra�c which enters the suite • Supervisor o�ce
Operation Theatre: Sta� Facilities
Nurse Counter
Change room, toilet, bath room,storage for scrub clothing
Toilet > red line > changing area
Locker
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Scrub Room: • Adjacent to OR, separate from OR (in a room) • Door swing out from scrub room to OR
Preparation (Holding) Area: • Between beds ≥ 1.5m • Bed to wall ≥ 0.9m
Stretcher Area
TIP Door at the scrub room need to swing out to ensure practicality to maintain sterility of the surgeons and the assistants performing the operation
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Operation Room (Major): • Area ≥38m2 [wall to wall] • Clear area ≥33m2 [exclusive of fixed or movable cabinets and shelves]
Note: R.190(1) ~ All operation theatre shall be designed as major operation theatres to achieve maximum flexibility in use
Operation Room (Minor): • Dimension ≥4.6m [Wall to Wall] • Clear area ≥25.0m2 [exclusive of fixed or movable cabinets and shelves]
Recovery Area:Multi-bedded – 13.9m2 per bed • Between bed 2.4m, • Between bed sides to wall 1.2m • Between foot of bed to wall 1.8m • Between foot of bed to foot of bed 2.1m
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Interlocking Hatch Box: • The function of the hatch box is to handle Instrument and waste disposal
Sterile Store Room
Clean Corridor Dirty Corridor
Dirty Utility RoomClean Utility Room Janitor’s Room
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Central Sterilizing and Medical-Surgical Supply Facilities and Services:The requirements are as below : • Location • Signs and Labels • Entrance and Exit • O�ce Space • Design and Flow (Sta� & Material Flow) • Facilities for Receiving, Disassembling and Cleaning • Facilities for Assembling and Packaging • Facilities for New Unsterile Equipment • Facilities for Sterilizing • Facilities for Storage of Clean and Sterile Supplies • Janitor’s Closet • Sta� Facilities
Location:In terms of location, the CSSD must be placed to satisfy these requirements: • To avoid contamination of clean and sterile supply and equipment • To prevent objectionable heat and noise to patient care areas • To eliminate through tra�c • To facilitate delivery and return of supplies and equipment
Entrance and Exit: • Separate service entrance • Adequate door size for large carts or bulk goods to pass through • All 2 way swing doors shall have vision panel • Separate entrance for clean and dirty equipment • Clearance at the bottom of exterior door ≤0.6cm • All doors except closet doors shall not swing into the corridors
O�ce Space: • Located within the main room to allow observation within CSSD with adequate desk and file space
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Facilities for Receiving, Disassembling and Cleaning: • Located to avoid transporting supplies through sterile areas within CSSD • Separate entrance for clean and dirty equipment • Facilities and services shall divided into work areas and may vary according to type of supply or equipment • Double compartment sink • Adequate ceiling height • Separate facilities for receiving bedside utensils (if not outsourced) • Separate facilities for cleaning bedside utensils (if not outsourced) • Separate and equipped solution preparation room
Facilities for Assembling and Packaging: • Adequate ceiling height • Facilities and services shall be divided into work areas and may vary according to type of supply or equipment • Double compartment sink • Work counter (washable) or its equivalent • Separate facilities for packaging bedside utensils (if not outsourced) • Floor and wall easy to wash and clean and non skid floor
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Facilities for New Unsterile Equipment: • Separate unsterile equipment storage room • Separated from facilities for sterile items and equipment • Adequate ceiling height • Floor and wall easy to wash and clean and non skid floor
Facilities for Sterilizing: • Dedicated area within CSSD • Located between assembling and packaging facilities and facilities for storage of clean and sterile supplies • Adequate ceiling height ≥2.7m • Floor and wall easy to wash and clean and non skid floor • Autoclave licensed under DOSH • Exhaust fan over sterilizer (autoclave) • Boiling water should not be used • Ventilation system to avoid contaminated air flow to clean or sterile areas
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Facilities for Storage of Clean and Sterile Supplies: • Dedicated and separated facilities within CSSD • Located to avoid transporting supplies through other areas within CSSD • Positive pressure • Ventilation system to avoid contaminated air flor to clean or sterile areas • Adequate ceiling height ≥2.7m • Floor and wall easy to wash and clean & non skid floor • Adequate cabinets
Sta� Facilities: • Commensurate with the type, scope and capability • Separate toilets for male and female sta�
Support Facilities: • Clean Utility Room • Dirty Utility Room • Janitor’s Room
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Coronary Care Unit (CCU)/High Dependency Unit (HDU): • Room/ward • Handwashing facilities • Door, corridor, ceiling • Window and ventilation • Areas for stretchers and wheelchairs • Nursing station • Appropriate patients’ medical record system facilities • Resuscitation facilities • Medicine preparation room/area • Examination and treatment room • Support/other facilities • Nourishment station or pantry • Clean utility room • Soiled utility room • Janitor’s closet • Toilet facilities • Bathing facilities • Refuse and hazard waste
Location:
Signs and Labels: • Proper signage and labelling system • Not to mislead the public on the type or nature of facilities or services
Avoid tra�cthroughfare
Free from unduenoise, heat and odour
Minimal electronicinterference
Patient rooms and ancillaryfacilities in same floor
Direct or remote viewingsystem on patients’ bed
or room from nurses station
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Corridor: • Size ≥ 2.1m wide (exceptions may be permitted for corridor limited to foot tra�c in a single department) • No beds shall be placed in corridors
Door:
Nurse Station: • 1 station: 36 patients • The location of patients room and placement of beds shall allow patients to be directly visible from nurses station • Area for writing patients’ records and charts at or nearby) • Clinical hand washing facilities (at or nearby) • With a nurse call system from patients • Communication system available within and with other facilities in electronic system • Call systems are kept in good repair and operating condition • Medication preparation room or area (at or nearby) • Toilet with hand washing facility for sta� (nearby)
Clear opening>1.2m (for patient care)
Clear opening patients’toilet and bathroom door
>0.9m’ not swing in,neither to corridor
Adequate size forlarge carts or bulk
goods to pass
All 2 way swingdoors shall have
vision panel
All doors except closetdoors shall not swing into
the coridors
Clearance at thebottom of exterior
door <0.6cm
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Single-Bedded Room: • Single-bedded room usable floor space ≥ 18.6m2 • Between head of bed and wall – adequate space for equipment • Between side of bed and wall ≥ 1.2m • Between foot of bed and wall ≥ 1.8m
Multibedded Room: • Usable floor space ≥ 13.9m2 • Between head of bed and wall–adequate space for equipment • Between side of bed and wall ≥ 1.2m • Between foot of bed and wall ≥ 1.8m • Between beds ≥2.0m • Between beds of opposing beds ≥ 2.0m
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HDU Patients’ Room:Single-Bedded Room • Usable
Multi-Bedded Room • Between head of bed and wall: adequate space for equipment • Between side of bed and wall ≥1.0m • Between foot of bed and wall ≥1.5m • Between bed ≥2.0m • Between feet of 2 opposing beds ≥2.0m
ICU Patient’s Room
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Patient’s Room Equipment: • Minimum 2 oxygen outlet, 1 suction outlet and 1 compressed air outlet per bed • Appropriate critical care/intensive care beds • Cubicle curtain • Curtains for windows • Emergency call system • Adequate facilities for therapeutic intervention, life support, back-up life support • Adequate vital sign monitoring facilities • Resuscitation facilities • Ventilation assisted equipment (eg. ambubag, airways) • Laryngoscope and endotracheal tubes • ECG monitoring with cardiac defibrillator • Suction equipment • Oxygen • Urinary catheters • Drugs (adrenaline, atropine, steroid, sodium bicarb) • Intravenous therapy • Basic obstetric supplies
Support Facilities: • Clean Utility Room • Dirty Utility Room • Janitor’s Closet
Special Care Nursery (SCN) & NICU:Basic Requirements for SCN and NICU • Location • Sign and labels • Special Care Nursery • NICU • Equipment and facilities • Support facilities
Location:May be within a paediatric care unit but separated from other patient care areas
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Dimension: • Area for each cot/incubator ≥3.3m2 • Distance between each cot/ incubator area ≥1.0m
Equipments: • Incubator or warmer • Emergency resuscitation equipment and supplies • Clinical sink • Newborn examination area
Equipments SCN/NICU:Example of specific equipments needed for SCN are:
Incubator or warmer• Emergency resuscitation equipment and supplies • Clinical sink• Newborn examination area
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Support Facilities:
Dirty Utility Room Janitor’s Closet
Medicine Preparation Area Clean Utility Room
Labour Room:Basic reguirements are as follow; • Location • Signs and Labels • Elevator • Corridor • Natural birthing room • Isolation (mother and infant) • Labour room • Equipment and facilities • First stage room (if provided) • Obstetric recovery room (if provided) • Nurse station • Medicine preparation room or area • Clean utility room • Soiled utility room • Janitor’s closet
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Location: • Free from undue noise (no disturbance to patients and sta�) • Avoid direct tra�c between labour room and operation theatre • Avoid outpatient tra�c through impatient areas • Proper signage and labelling system
Labour Room: • Each room shall be maintained as a separate unit with equipment and supplies • Door clear opening ≥1.2m and not swing into the corridors • No window/window sealed added with curtain • Dimension ≥ 3.7m and Clear area ≥ 17m2
• Ceiling height ≥ 2.7m with special ceiling-mounted light fixtures • Clinical sink • Portable incubator • Equipment and supplies for normal SVD supplies and immediate care of normal newborn such as suction apparatus, radiant warmer and oxygen • Resuscitation facilities for mothers and infants
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Nurse Station: • 1 station: 36 beds • Distance ≤ 24.4m from patients’ rooms • Area for writing patients’ records and charts (at or nearby) • Clinical hand washing facilities (at or nearby) • With a nurse call system from patients • Call systems are kept in good repair and operating condition • Medication preparation room or area (at or nearby) • Toilet with hand washing facility for sta� (nearby)
First Stage Room (Optional): • Located close to labour room and postpartum unit • Dimension ≥ 3.7m; clear area ≥ 17m2 with max capacity of 2 beds • Door size ≥1.2m and not swing into the corridors • Adequate ceiling height (air condition ≥ 2.4m, if not ≥ 3.0m)
Equipment and Facilities Include: • Clinical sink • Portable incubator • Equipment and supplies for normal SVD supplies and immediate care of normal newborn such as suction apparatus, radiant warmer and oxygen • Resuscitation facilities for mothers and infants • Pharmaceutical refrigerator for vaccines
TIPThere should be No window in labour room(if available, window shall be sealed and added with curtain)
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Resuscitation Facilities:8th Schedule (a) An emergency call system (b) Oxygen (c) Ventilation assistance equipment (e.g. ambubag) (d) ECG monitoring with cardiac defibrillator (e) Intravenous therapy (f) Laryngoscope and endotracheal tubes (g) Suction equipment (h) Urinary catheters (i) Drugs (Adrenaline, Atropine, Steroid, S.Bicarb) (j) Basic obstetric supplies
Equipment and Facilities: • Portable incubator • Resuscitation facilities for mothers and infants • Nurse station • Medicine preparation room/area • Clean utility room • Dirty utility room • Janitor’s closet
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Resuscitation Facilities:8th Schedule (a) An emergency call system (b) Oxygen (c) Ventilation assistance equipment (e.g. ambubag) (d) ECG monitoring with cardiac defibrillator (e) Intravenous therapy (f) Laryngoscope and endotracheal tubes (g) Suction equipment (h) Urinary catheters (i) Drugs (Adrenaline, Atropine, Steroid, S.Bicarb) (j) Basic obstetric supplies
Equipment and Facilities: • Portable incubator • Resuscitation facilities for mothers and infants • Nurse station • Medicine preparation room/area • Clean utility room • Dirty utility room • Janitor’s closet
Nursery:The basic requirements are: • Newborn nursery room • Nursery equipment • Isolation of newborn • Newborn feeding • Clean utility room • Soiled utility room • Janitor’s closet
Location: • Adjacent to post partum unit and free from tra�c flow • Ancillary facilities outside nursery room • Provision for viewing newborn by visitors from outside newborn nursery room
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Newborn Nursery Room: • Facilities with obstetric or midwifery care or newborn care shall include a newborn nursery with ancillary facilities • A control area to serve as a work space and nursery entry • Only authorized nursing sta� is permitted • Provision for viewing newborn by visitors from outside newborn nursery room • Rooms are well-lighted • Hands free hand washing facility and gowning area located at the entrance or immediately outside nursery
Equipment in a Newborn Nursery Unit: • Easily cleaned bassinet for each newborn • Bassinets from walls ≥ 15.2cm • Between bassinets ≥ 0.3m • Aisles for passageways ≥ 0.9m wide • Storage compartment (in bassinets or on individual table) • Incubator or warmer • Emergency resuscitation equipment and supplies • Weighing scale • Gas outlets ( oxygen, compressed air ) 1 : 4 bassinets • Clinical hand washing facilities • Newborn examination area, adjacent to nursery: 1 area ≥ 24 bassinets • Diaper, soiled linen and waste receptacles with foot controls and disposable impervious liners
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Isolation of Newborn: • Immediate isolation room for newborn from outside or having infectious diseases or any infection • Isolation shall be carried out through any of the following: • An intensive care nursery • Another newborn nursery unit - Isolation room with separate scrub facilities - Referring to an intensive care referral centre
Special Care Nursery: • Area for each cot or incubator ≥ 3.3m2 • Distance between each cot or incubator treatment area ≥ 1.0m • At least with one incubator • The location of patients room and placement of beds (cots) shall allow patients to be directly visible from nurses station
Emergency Resuscitation Equipment and Supplies: • Resuscitation warmer, towel or blankets • Bulb syringe, mechanical suction and suction tubing, 10F and 12F suction catheter • Meconium aspirator • Infant stethoscope • Oxygen tubing, mask for term and preterm babies, oxygen • Self inflating bag with reservoir or T-piece resuscitator with appropriate adapter • Pulse oxymeter and probe for newborn use • Laryngoscope with straight blade size 0, size 1 • ETT tube sizes 2.5, 3.0 and 3.5 • Stylet (optional) • Scissors, securing tape • Medication – adrenaline 1:10000, normal saline 500mls, naloxone • Assorted syringes, needles • Chemically activated warming pad or food grade plastic wrap (for keeping preterm infant warm) • Transport incubator, portable oxygen and air cylinders • Equipment for emergency placement of umbilical venous catheter (optional)
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Milk Formula Preparation Room: • Located within a newborn nursery unit • Separate clean and dirty/soiled areas • Clean area for preparation, thermal heating and storage. • Work counter • Sink • Thermal heating equipment • Refrigerator equipped with thermometer • No cabinets above the milk preparation area • Soiled area for receiving and washing bottles, teats and other related utensils
Medicine Preparation Room or Area: • Locked cabinet for dangerous drug • Work space for preparation of medication • Sink with hand washing facilities • Refrigerator with thermometer and exclusively for pharmaceutical storage • No test reagents, general disinfectants, cleaning agents and similar products in this room or area
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Support Facilities: • Clean Utility Room • Dirty Utility Room • Janitor’s Closet
Blood Bank: • Waiting area • Reception area/nurse station • Medicine preparation room or area • Examination and treatment room • Resuscitation facilities • Bleeding area • Donor recovery area/nourishment station or pantry • Work/processing area • O�ce space • Store area • Clean utility room • Soiled utility room • Janitor’s closet
Location: • Free from undue noise (no disturbance to patients and sta�) • Not exposed to excessive smoke, foul odours or dust • Construction prevents entrance and harbourage of rodents and insects • Proper signage and labelling system • Adequate area for hanging laboratory coats near the entrance or exit door • Area for stretchers and wheelchairs
Waiting Area: • Separated waiting area from work area • Door size ≥1.2m wide (for patient care) • Adequate ceiling height (air condition ≥ 2.4m, if not ≥ 3.0m)
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Bleeding Area: • Separated bleeding area from work area • Su�cient space to perform activities and work with e�ciency and safety • Consumables and equipment for blood collection comply with 10th Schedule (Appendix 1) • UPS for plasmapheresis and apheresis • Space provided for acceptable movement of materials and personnel with minimal tra�c and for relevant activities to be carried out
Donor Recovery Area/ Nourishment Station or Pantry: • Separated donor recovery area from work area • Door size ≥1.2m wide (for patient care) • Adequate ceiling height (air condition ≥ 2.4m, if not ≥ 3.0m) • Su�cient space to perform activities and work with e�ciency and safety • Sink with hand washing facilities • Serving equipment (between schedule meals) • Refrigerator • Storage cabinet
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Work/Processing Area: • Separated from reception area, bleeding area and donors recovery area • Su�cient space to perform activities and work with e�ciency and safety • Space provided for acceptable movement of materials and personnel with minimal tra�c and for relevant activities to be carried out • Washable surfaces • Adequate work bench space for handling, processing, testing samples and placement equipment and reagents • Where corrosive materials are used-surfaces and floor of corrosive-resistant materials. • Consumables and equipment for blood bank laboratory work comply with 10th Schedule (Appendix 2) • Consumables and equipment for component preparation comply with 10th Schedule (Appendix 3) [including freezer (-40oC with temperature monitoring system)] • Adequate and stable electrical source for high precision equipment • Sink, water and electrical outlets located conveniently to the work area • Doors directly lead to the outside shall be sealed and used for emergency only
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O�ce Area: • Separated o�ce space from work area
Store Area: • Storage facilities for documentation, data storage and data retrieval • Adequate and appropriate consumables and equipment • Adequate store room for supplies, consumables, equipment
Support Facilities: • Clean Utility Room • Dirty Utility Room • Janitor’s Closet
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Emergency Department:Emergency departments are where all the emergency and trauma cases are first seen. The basic requirements are as follows: • Location • Sign and label • Nature and scope of facility and service • Entrance and Exit • Ramp • Stretcher and wheelchairs • Door • Corridor • Floor and Wall • Ceiling • Ventilation • Registration area • Waiting area • Display area • Reception and control area • Communication system • Nurse station • Medicine preparation room/area • Resuscitation facilities • Emergency treatment room • Examination/treatment room • Observation room/area • Electrical Supply • Plumbing • Refuse and Hazardous • Sewage and sewerage system • Toilet facilities • Clean Utility Room • Dirty Utility • Janitor’s Closet
Location: • Easily accessible from the street • Free from undue noise (disturbance to patients and sta�) • Not exposed to excessive smoke, foul odours or dust • Appropriately located to radiological and laboratory services • Separated from labour room, surgical suite and surgical obstetrical suites
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Signs and Labels: • Proper signage and labelling system • Well marked and illuminated signboard • Not to mislead the public on the type or nature of facilities or services
Entrance and Exit: • Entrance is su�ciently covered and enclosed to protect patients during the unloading process from the ambulance
Emergency Entrance for Ambulance: • Dedicated emergency entrance (accessible to pedestrian, ambulance and tra�c) • Ambulance drop o� area direct access to resuscitation room/area
Emergency Entrance for Pedestrian: • Dedicated emergency entrance (accessible to pedestrian, ambulance and tra�c)
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Reception and Control Area (Triage): • Located adjacent to emergency entrance • Receiving and assessment (triage) area • With visual control of the entrance, waiting room and treatment area
Stretcher and Wheelchair Park: • Space located adjacent to emergency entrance • Stretchers su�ciently sturdy to serve as examining table (preferably x-ray permeable)
Stretcher Area
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Waiting Area (May be combined with other Waiting Area): • Located outside the main tra�c flow in the unit • With toilet, telephone, drinking facilities
Emergency Treatment Room (Resuscitation Room): • Doors size ≥1.2m and not swing into the corridors • Adequate ceiling height (air condition ≥2.4m, non-air condition ≥3.0m) • Dimension ≥3.0m • Area ≥11.1m2
• Sink and hand washing facilities • A nurse call system (within easy reach of each bed) • Located near to nurse station • Examination light • Cubicle curtains for each bed/table/trolley for complete patient privacy • Numbers, types and equipment commensurate with scope and type of services and patient load
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Observation Room/Area: • Doors size ≥1.2m and not swing into the corridors • Adequate ceiling height (≥2.4m, air condition or ≥3.0m) • Dimension ≥3.0m • Area fo single bedded room ≥10.0m2
• Clear space between sides/foot of bed from walls ≥0.9m • For multiple bedded room 1.5m between beds • A nurse call system (within easy reach of each bed) • Sink and hand washing facilities • No beds shall be placed in corridors or other than patient room areas except in case of emergency • Distance from nurses station ≤ 24.4m • Examination light • Cubicle curtains for each bed/table/trolley for complete patient privacy • Numbers, types and equipment commensurate with scope and type of services and patient load
Yellow Zone Red Zone
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Asthma Bay: • Doors clear opening ≥1.2m and not swing into the corridors • Area ≥4.5m2 / recliner chair • Located near to nurse station • Cubicle curtains for each bed/table/trolley for complete patient privacy • Sink and hand washing facilities
Treatment Room: • Doors size ≥1.2m and not swing into the corridors • Adequate ceiling height (air condition ≥2.4m, non-air condition or ≥3.0m) • Dimension ≥3.0m • Area ≥11.1m2
• Sink and hand washing facilities • Distance from nurses station ≤ 24.4m • Examination light • Cubicle curtains for each bed/table/trolley for complete patient privacy • Numbers, types and equipment commensurate with scope and type of services and patient load
Treatment Room Examination Room
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Disabled Toilet: • Clear opening for patient’s toilet door ≥0.9m and not swing inward, neither into corridor • Disabled person-friendly (fit in wheel chairs) with: - Incombustible waste-paper receptacle with removable impervious liner • Grab bar • Nurse call system • Hand washing facilities • Toilet for healthcare professional in each patient care unit • Separate toilet for male and female sta� • No carpet
Radiology and Imaging Facilities:The basic requirements are as follows: • Location • Signs and Labels • Ramp • Entrance and Exit • Corridor • Floor and Wall • Ceiling • Window and Ventilation • Electrical Supply • Plumbing • Hand Washing Facilities • Resuscitation Facilities
Facilities for Radiological or Diagnostic Imaging Services: • Administrative facilities (may share with adjacent services) • A reception area, separate from the work area • A radiographic room • Light proof, dark room with equipment • Changing room or area • Easy access to toilet from radiographic room • Therapy room, if applicable
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Facilities for Radiotherapy and Radioisotope Services: • Impermeable and readily decontaminated work surfaces and floors • Adequate equipment and protective devices in radiochemistry laboratory to ensure safe storage and handling • Patient up-take measuring room-appropriately located or adequately shielded
Waiting Area: • Administrative facilities (may share with adjacent services) • A reception area, separate from the work area • A radiographic room • Light proof, dark room with equipment • Changing room or area • Easy access to toilet from radiographic room • Therapy room, if applicable
Reception/Registration Counter
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Interventional Radiology:
Interventional Radiology (IR), also known as Vascular And Interventional Radiology (VIR) or Surgical Radiology, is a sub-specialty of radiology providing minimally invasive image-guided diagnosis and treatment of diseases in every organ system.
Although the range of procedures performed by interventional radiologists is broad, the unifying concept behind these therapies is the use of the most modern, least invasive technique available in order to minimize risk to the patient and improve health outcomes.
Angiography
As the inventors of angioplasty and the catheter-delivered stent, interventional radiologists pioneered modern minimally invasive medicine. Using X-rays, CT, ultrasound, MRI, and other imaging modalities, interventional radiologists obtain images which are then used to direct interventional instruments throughout the body.
These procedures are usually performed using needles and narrow tubes called catheters, rather than by making large incisions into the body as in traditional surgery
Fluorosopy:Fluoroscopy is an imaging technique that uses X-rays to obtain real-time moving images of the interior of an object. In its primary application of medical imaging, a fluoroscope allows a physician to see the internal structure and function of a patient, so that the pumping action of the heart or the motion of swallowing, for example, can be watched.
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Bone Densitometer:
Bone Densitometry is a test like an x-ray that quickly and accurately measures the density of bone.
It is used primarily to detect osteopenia or osteoporosis, diseases in which the bone's mineral and density are low and the risk of fractures is increased
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Hemodialysis Facilities:Hemodialysis facilities function to provide haemodialysis services for the haemodialysis patients. The basic requirements are as follows: • Administrative facilities • Dialysis area/room (chair/bed) • Isolation: Hepatitis B/C/HIV etc • Dialysis Machine • Dialysate Fluid • Dialyser • Dialyser Reprocessing room • Dialyser storage • Water supply • Water treatment room • Water treatment system • Support facilities
Location: • Free from undue noise • Not exposed to excessive smoke, foul odours or dust • Avoid through tra�c to any other service, diagnostic or administrative facility • Avoid outpatient tra�c through inpatient areas • Physically separated from other facility and service (functional zoning) • Construction prevents entrance and harbourage of rodents and insects
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Waiting Area: • Separated from treatment area (for patient privacy) • Clear opening to treatment area ≥1.2m
Corridors: • Size (clear opening) ≥ 2.1m wide (for dialysis treatment area may ≥ 1.0m) • No beds or dialysis chairs shall be placed in corridors
Corridor ≥ 1.0m
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Floors and Walls: • Easy to wash and clean and non skid (for floor) • Non-toxic (safe)
Clinical Examination and Treatment Room: • Doors size ≥1.2m (clear opening) and not swing into the corridors corridors • Adequate ceiling height (air condition ≥2.4m, if not ≥ 3.0m) • Dimension ≥ 3.0m • Area ≥ 11.1m2
The consultation/treatment room should have barrier to protect privacy of patients
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Dialysis Machine: • Area ≥ 4.5m2/patient • Separate of each categories e.g. Hep B/Hep C and Hep B/C
Dialysis area ≥ 4.5m2/ Dialysis area ≤ 4.5m2/
If using beds, the distance should be 1.5m in between beds and 0.9m from the wall.
There should be no labelling of Hepatitis B/ Hepatitis C/HIV at the isolation rooms to prevent stigmatization of the public to the patient
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Dialyser: • Made from biocompatible membrane shall be used. e.g. - Polysulphone - Synthetic hollow fiber polynephron - Ceruphane • Single use dialyer for hepatitis treatment
Reprocessing Room (If Dialysers are Reused): • Separated from dialysis area and patient care • Disposables are processed separately for each category of patient • Air discharge exhaust located to avoid cross circulation to air supply intakes or windows • Air from rooms or areas likely to contain infectious micro-organisms shall be exhausted and not re-circulated through the normal air-conditioning system • Separate storage dialysers’ container for each patient and category
Dialyser Reprocessing Machine (If Dialysers are Reused): • Approved by DG (the reprocessing machine shall be a fully automated integrated unit) • Located in a reprocessing room • Dedicated machine for each category of patient
NON HEPATITIS HEPATITIS C
Criss-Crossing
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Water Supply: • Safe and su�cient water supply according to standards approved by relevant authority (preferably enough for usage ≥ 2 days) • Minimum capacity : 300L x No. of machine x No. of shifts • Raw water tank is properly maintained and made up of material approved by relevant authority: - Stainless steel-grade 316 - High-density polyethylene (HDPE)
Water Treatment Room:• Pipes for treated water made of acrylonitrile butyldiene styrene (ABS) material, cross-linked polyethylene (PEX), stainless steel (high grade 316L) and as approved by the DG• Arrangement of the systems as follows:• Multimedia/Sediment column-undisolved particles (500-5microns)• Carbon column 1, Carbon column 2• Chlorine, Chloramine• Softener column-remove Calcium, Magnesium• Brine tank-regenerate Sodium Chloride
Water tanks should not be using material which can be rusty over time and have a proper location (not at the roadside) to ensure safety.
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Water Treatment Rooms: • Brine tank-regenerate Sodium Chloride • RO module-microbiological barrier (bacteria, endotoxin, pyrogens and viruses) • Central Delivery System (CDS) tank (indirect)-RO water storage tank • Post carbon column 1/Post carbon column 2/Post softener column/pre RO module/ Immediate post RO module (optional) • First point in the distribution loop • Last point in the distribution loop • Last point of the dialyser-reprocessor loop
Sample of schematic direct feed system
Product
Return
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Janitor Closet: • Sink (preferably with a floor receptor with mixing taps) • Hook strip for mop handle • Shelf for cleaning material
Sewage and Sewerage System: • No exposed sewer line located directly above working, storing or eating surfaces or areas or where medical or surgical supplies are prepared, processed or stored
Refuse and Hazardous Waste:Waste management is especially important haemodialysis unit. The requirements are: • Kept in impervious, non-absorbent with tight-fitting lids and easily washed containers • Su�cient number of sound watertight containers with tight fitting lid • Separate handling of infectious and non-infectious waste at the point of generation • Proper disposable of infectious waste in designated containers • Handling of non infectious waste in accordance with good safety practice and related law • Handling all hazardous waste in accordance to relevant authority to protect persons and environment • Take all necessary precaution to dispose infectious waste • Store area for clinical waste awaiting disposal
Clinical waste holding area must be organized
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Toilet Facilities: • Clear opening for patients' toilet door ≥ 0.9m and not swing inward, neither into corridor • Grab bar • Nurse call system • No carpet
Location: • Easy access by outpatients • Convenient access to related/relevant services • Avoid outpatient tra�c through inpatient area
Specialist Outpatient Clinic: • Location • Signs and labels • Ramp • Entrance and exit • Area for stretchers and wheelchairs • Stairway • Elevator • Corridor • Floor and wall • Window and ventilation • Electrical supply • Plumbing • Handwashing facilities • Water supply • Refuse and hazardous waste • Sewage and sewerage system
• Administrative facilities • Display area • Medical record system facilities • Medicine preparation room or area • Resuscitation facilities • Consultation room • Treatment room (if provided) • Minor Surgery room (if provided) • Outpatient Dental Services (optional) • Clean utility room • Soiled utility room • Janitor’s closet • Patient toilet • Sta� facilities • Public amenities
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Signs and Labels: • Proper signage and labelling • Not to mislead the public on the type or nature of facilities or services
Entrance and Exit: • Entrance designed for wheel chairs and stretchers - Separate patient and visitors entrance - Separate emergency entrance (accessible to pedestrian, ambulance and tra�c) • Separate exit for deceased (no obstruction)
Area for Stretchers and Wheelchairs
Entrance to specialistclinic (separated)
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Administrative Facilities: • Adequate waiting room or area • Reception/registration area • Administrative oce or area
Medication Preparation: • Locked cabinet for dangerous drugs • Work space for preparation of medication • Sink with hand washing facilities • Refrigerator with thermometer and exclusively for pharmaceutical storage
Consultation Room vs Treatment Room
Consultation Room Treatment Room
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Consultation Room: • Dimension ≥ 3.3m • Area ≥ 11.1m2
• Facilities including: (i) Hand washing facilities (ii) Examination light (iii) Storage of supplies and equipment (iv) Dressing cubicle or area (v) Screen for privacy of patients (vi) Film illuminator
Treatment Room: • Dimension ≥ 2.4m, area ≥ 8m2
• Facilities including: (i)Hand washing facilities (ii)Examination light (iii)Storage of supplies and equipment (iv)Dressing cubicle or area (v)Screen for privacy of patients (vi)Film illuminator• Shall comply with requirements as a treatment room as required under Part XV
Dimension ≥ 2.4m, Area ≥ 8m2
Dimension ≥ 2.4m
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Dental Treatment Room: • Area for dental surgery room ≥ 6.0m2
• Adequate dental surgery equipment and dental surgery materials • Adequate storage facilities for dental equipment and dental materials • Adequate and appropriate storage for housing the dental compressor • Adequate sterilising facility (su�cient capacity) • Distance between arm rest ≥ 1.2m (if > 1 dental chair)
Support Facilities: • Clean Utility Room • Dirty Utility Room • Janitor’s Room • Disabled Toilets
Basic Rehabilitation Facilitiy Requirements: • Location • Signs and labels • Entrance and Exit • General facilities: i) Waiting area ii) Areas for stretchers and wheelchairs iii) Receptions iv) Toilet, locker and shower facilities • Functional zoning • Facilities/Equipment – Patients – Sta� • Play area • Accommodation for patients • Medicine preparation room/area • Resuscitation facilities • Physical, occupational, psychological, social service and vocational facilities
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Corridors: • Size ≥ 2.1m wide (exceptions may be permitted for corridor limited to foot tra�c in a single department) • Handrails (compulsory for patients with physical disabilities unit i.e. orthopaedic and rehabilitation units) • No beds shall be placed in corridors
General Facilities: • Waiting area • Space for stretchers and wheelchairs • Reception counter or desk
Patients Ward/Room: • Separated for male and female ( ≥ 12 year-old) • Door size ≥ 1.2m and not swing into the corridors • Adequate ceiling height (air condition ≥ 2.4m, if not ≥ 3.m) • Dimension for single-bedded room ≥ 3.0m • Area for single-bedded room ≥ 10.0m2 • Clear space between sides/foot of bed from walls ≥ 0.9m • For multiple bedded room: ≥ 1.5m between beds • Separate locker for each patient • Bed head lamp/toilet lights/nights lights/lights switch adjacent to doors to patients’ room • A nurse call system (within easy reach of each bed) • Cubicle curtains with built-in curtain tracks • Hand washing facilities • Patient with infectious and communicable diseases shall not be admitted with non-infectious or non-communicable diseases • No beds shall be placed in corridors or other than patient room areas except in case of emergency • Distance from nurses’ station ≤ 24.4m
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Toilets: • Clear opening for patients’ toilet door ≥ 0.9m and not swing inwards, neither into corridor • Ratio 1 toilet: 4 beds: adjacent or within patients’ room. • Disabled person-friendly (fit in wheel chairs) with: - Incombustible waste-paper receptable with removable impervious liner - Grab bar - Nurse call system - Hand washing facilities - Toilet for healthcare professional in each patient care unit - Separate toilets for male and female sta�
Bathing Facilitiy: • Grab bar • Nurse call system in adequate space to fits in wheelchair • Clear opening for patient’s bathroom door ≥ 0.9m and not swing inward, neither into corridor • No carpet • No laundry conducted here
Examination Room: • Doors clear opening ≥ 1.2m and not swing into the corridors • Adequate ceiling height (air condition ≥ 2.4m, if not ≥ 3.0m) • Dimension ≥ 3.0m • Area ≥ 11.1m2
• Hand washing facility • Examination light • Storage for linen, supplies and equipment • Examination and treatment couch • Screen or curtain for patient privacy • Located near nurses stations or where patient care is provided or procedure is carried out • Contaminated equipment shall not be used for patients
Grab bar
Nurse call system
Hand washing facilities
Dimension ≥ 3m, area ≥ 11.1m2
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Medicine Preparation Area: • Locked cabinet for dangerous drug • Work space for preparation of medication • Sink with hand washing facilities • Refrigerator with thermometer and exclusively for pharmaceutical storage. • No test reagents, general disinfectants, cleaning agents and similiar products in this room or area
Resuscitation Facilites: • Ventilation assistance equipment (e.g ambulag) • Laryngoscope and endotracheal tubes • ECG monitoring with cardiac defibrillator • Suction equipment • Oxygen • Urinary cathethers • Drugs (adrenaline, atropine, steroid, S.Bicarb) • Intravenous therapy
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Play Area: • Adequate play area and facilities for the children
Physical Therapy Facilities: • Suitable administrative facilities • Examination room with equipment • General treatment area • General exercise area with flexible open space • Underwater exercise area, if any • Lockers in or near treatment areas • Adequate storage area for supplies and equipment • Hand washing facilities • ≥1 suitable sink to accommodate wet packs • Ceiling moorings well-constructed (to support ≥230kg overhead equipment)
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Occupational Therapy Facilities: • Located close to physical therapy facilities. • Administrative facilities with visual supervision of therapy areas • Appropriate and adequate equipment • Storage areas for supplies and equipment • Therapy area ≥ 3.3m2 of floor area per patient • Facilities for teaching activities of daily living
Psychological Service Facilities: • O�ce and work space for sta� • Dedicated room for patients • Room for psychological testing • Room for evaluation • Room for counselling of patients • O�ce and workspace for sta�
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Support Facilities: • Clean Utility Room • Dirty Utility Room • Janitor’s Closet
Social Service Facilities: • O�ce and work space for sta� • Dedicated room for patients • Room for private interview • Room for counselling of patients
Pharmacy:The location requirements for pharmacy are as follows: • Outpatient pharmacy near or adjoining outpatient department • Inpatient pharmacy clean room @ area accessible to nursing unit • Adequate space and relevant equipment for all pharmacy operations
Waiting room: • Waiting room and pharmacy o�ce may be provided
Note:Hospital with ≥ 50 beds-licensed pharmacist Hospital with < 50 beds-licensed pharmacist/RMP In house drugs manufacturing requires licensed pharmacists
Dispensing Unit: • Dispensing counter • Work counter with impermeable surface • Corrosion-resistant sink • Storage unit (may be moveable with drawers) • Pharmaceutical refrigerator with thermometer and freezing compartment • Locked storage for dangerous drug and other controlled drug • Separate storage room for inflammable chemicals and reagents
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Compounding Unit: • Work counter with impermeable surface • Corrosion-resistant sink • Storage unit • Pharmaceutical refrigerator with thermometer and freezing compartment • Locked storage for dangerous drug and other controlled drug • Separate storage room for inflammable chemicals and reagents
Manufacturing Area: • Comply with Good Manufacturing Practices (GMP) • Separate areas for preparation of cytotoxic drug or radioactive material preparation • Su cient storage facilities and accordance with Good Storage Practices issued by a competent authority
Kitchen:The requirements are as follows: • Location • Signs and label • Entrance and Exit • Ventilation • Sewage and sewerage system • Administrative facilities • Receiving area • Refrigeration area
• Storage (food vs non food items)• Preparation and cooking area• Serving area• Dining area• Dish washing area/room• Kitchen waste• Toilet and shower
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Location: • Located to facilitate delivery of stores, transportation of food to nursing units and disposal kitchen waste • Construction prevents entrance and harbourage of rodents and insects
Entrance and Exit: • Dedicated entrance (for entrance, store etc.) • Clearance at bottom of the door ≤ 0.6cm
Receiving Area: • Provided and located for ready access to refrigeration area • Adequate space for movement the carts throughout the dietary facility and services • Adequate space and equipment for receiving and storing • Food receiving area shall be provided and located for ready access to refrigeration area
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Refrigerator Area: • The temperature of the refrigeration units shall be 0oC to 4oC • Storage for frozen food shall be provided and maintained at –20oC. • Ice facilities (if provided) shall be located as to avoid contamination and tra�c through kitchen
Storage of Food: • The bulk food storage room shall be accessible from outside the delivery entrance and located conveniently for the kitchen • Food and non-food items shall be stored separately • Food storage room shall be such as to prevent entrance and harbourage of rodents
Preparation and Cooking Area: • Adequate space and equipment for preparation and cooking • The floors of kitchens shall be easy to clean, non-skid, impervious and kept in good repair • The walls and ceilings shall have a smooth washable surface, be kept clean and in good repair • Adequate space for movement the carts throughout the dietary facility and service • Separate meat, fruits and vegetables preparation area • May provide a special diet preparation and bakery areas within the cooking area • A cooking area shall be located between preparation and serving areas
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Cooking Area: • A cooking area shall be located between preparation and serving areas
Serving Area: • Adequate space and equipment for serving • Adequate space for mobile equipment and equipped with adequate serving and beverage services equipment • The floors of kitchens shall be easy to clean, non-skid, impervious and kept in good repair • The walls and ceilings shall have a smooth washable surface, be kept clean and in good repair
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Dining Area: • Adequate space and dining equipment
Dishwashing Area: • Adequate space and equipment for dish washing • A separate washing room or area shall be provided for washing pots and pans and serving and beverage services equipment • The floors of kitchens shall be easy to clean, non-skid, impervious and kept in good repair • The walls and ceilings shall have a smooth washable surface, be kept clean and in good repair
Kitchen Waste: • Kitchen waste may be combined with general waste disposal • Raw or processed food are not to be transported to and from the kitchen area together with any kitchen waste • Adequate space for garbage containers
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Toilet and Shower: • Adequate toilets and shower facilities and shall not be opened directly into any food preparation area
Laundry:The general requirements are as follows: • Location • Signs and labels • Entrance and Exit • Ventilation
The specific requirements are : • Laundry facilities or services • Handwashing facilities • Toilet facilities • Handling and removal of linen • Janitor’s closet • Clean linen storage room or area
Location: • No laundry operations in patient room/toilet/food preparation area
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Entrance and Exit: • Separate service entrance • Located close to storage room or area • Adequate door size for large carts or bulk goods to pass through (for entrance, store etc.)
Ventilation: • Well ventilated with negative pressures relative to any adjacent room • Air movement from the cleanest room to the most contaminated area • Laundry exhaust shall be above the roof or 15.2m away from any window and shall not discharge at or near any fresh air inlet
Facilities and Services: • The laundry facility shall have su�cient capacity to process a continuous supply • Laundry facilities or services: • Safety appliances and sanitary requirements • Minimal material transportation and operation • Avoid cross operation • Provide storage between operations • Designed and installed in compliance with all local by-laws • Hand washing facilities and toilet
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Clean Linen Storage Room or Area: • A clean linen storage room or area shall be provided separate from the laundry
Janitor’s Closet: • Sink (preferably with a floor receptor with mixing taps) • Hook strip for mop handle • Shelf for cleaning material • Waste receptacle with impervious linear • Hand washing facility • Adequate space for mop, bucket and cleaning equipment
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CHAPTER 4APPLICATION FORLICENCE TO OPERATE
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This chapter addresses the procedure to obtain Form 4,the licence to operate and provide under Act 586.
4.0 Introduction
The application form can be downloaded from the website of Medical Practice Division (www.medicalprac.moh.gov.my) or obtained from Private Medical Practice Control Section (CKAPS) either in Putrajaya or State Health O�ce. Please refer to Prosedur Permohonan-permohonan Berkaitan Perakuan Kelulusan dan Lesen bagi Hospital Swasta (Procedures of Applications for Certificate of Approval and Licence for Private Hospitals), available at the website as well.
The complete application form (Form 3 in 2 copies) and supporting documents must be submitted together to the Medical Practice Division with processing fee as prescribed below:
• 2 copies complete application form (Form 3) together with the supporting documents and processing fee must be submitted. • The processing fee is RM1,500 + (RM5 x every bed). E.g. a hospital with 1,000 beds, the processing fee will be RM1,500 + (RM5 x 100) = RM2,000- paid to the Secretary General of Ministry of Health. • Letter of acknowledgement and receipt of the processing fee will be sent to the applicant after the application is received. • The application will be processed and the hospital will be inspected to ensure compliance towards the legal provisions and built as per approved floor plans • The findings will be presented to the Evaluation Committee • Once application is approved or rejected, the applicant will be notified of the decision of the Committee. • For an approved application,a letter asking for payment of licence issuance fee will be sent to the applicant. Licence will be issued once the applicant has made the payment. • The fee is to be paid to Secretary General of the Ministry of Health in the form of money order or bank draft.
4.1 How to Apply?
The most important part is to ensure that the facilities are built according to the approved floor plans and has the personnels commensurating to the services intended to be provided.
4.2 Factors to be Considered
No of beds <25
3,000
25-49
4,000
50-99
5,000
100-199
6,000
>199
8,000Issuance fee(RM)
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CHAPTER 5QUESTIONS ANDANSWERS
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1. Where can I get the application forms and more informations on setting up private healthcare facilities in Malaysia?
Interested parties may go to Medical Practice Division’s website at www.medicalprac.moh.gov.my. There are a lot of relevant materials pertaining to application to set up healthcare facilities under Act 586 there, amongst others are application forms, checklists, guidelines, Minister’s and Director General of Health’s directives
2. Who can I contact to raise my queries?The applicants may write to:
Private Medical Practice Control SectionMedical Practice Division,Ministry of Health Malaysia,Level 3, Block E1, Parcel E,Federal Government Administration Centre, 62590 PutrajayaTel: 03-88831307 Fax: 03-88810902
Alternatively, the applicants may also email to [email protected].
3. How high can a private hospital be designed in Malaysia?
The maximum height recommended is 12 clinical floors or 48 meters high (whichever lower). However, should you want to build a healthcare facility exceeding those requirements, the applicant need to submit a practical comprehensive Hospital Disaster Management Plan, relevant to the scope of healthcare facilities and services intended to be provided by the hospital.
4. Can a private hospital be built from existing building (not purpose-built)?
Till date, there is no hospital set up in existing building that can comply fully to the requirements of Act 586 as it is di�cult for an existing building to comply with the requirements of major infrastructures under Act 586 such as lifts, ramps, landings, stairways, corridors and ceiling heights
5.0 Questions and Answers
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ACKNOWLEDGEMENTDr. Ahmad Razid bin Salleh Director, Medical Practice Division, MOH
En. Zahid IsmailDirector, Malaysia Productivity Corporation.
Dr. Afidah binti AliDeputy Director, Private Medical Practice Control Section, Medical Practice Division, MOH
Dr. Siti Zufina binti Abd SamahSenior Principal Assistant Director, Private Medical Practice Control Section, Medical Practice Division, MOH
Dr. Alicia Liew Hsiao HuiSenior Principal Assistant Director, Private Medical Practice Control Section, Medical Practice Division, MOH
Dr. Nurul 'Ain binti SelamatPrincipal Assistant Director, Private Medical Practice Control Section, Medical Practice Division, MOH
Dr. Mohd Azran Hafiz bin AhmadPrincipal Assistant Director, Private Medical Practice Control Section, Medical Practice Division, MOH
Dr. Nuraisyah Chua AbdullahAssociate Professor, Faculty of Law, Universiti Teknologi MARA
Mohamad Azrol Mohamad DaliSenior Manager, Malaysia Productivity Corporation
Khalidatul Asrin Abdul AzizManager, Malaysia Productivity Corporation
Azimah AdnanManager, Malaysia Productivity Corporation
Nur Syafina AnuarAssistant Manager, Malaysia Productivity Corporation
Rabiatul Hana IshakAssistant Manager, Malaysia Productivity Corporation
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NOTES
Ministry of HealthBlock E1, E3 , E6 , E7 & E10, Parcel E,
Federal Government Administration Centre,62590, Putrajaya Malaysia
www.moh.gov.my